Arthrex® AR-8400OBERecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00888867043602), received between Jan 19, 2018 and Apr 1, 2026 — classified as 16 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (24 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE CONNECTOR OF THE DEVICE BROKE DURING USE. THIS HAPPENED OUTSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757042 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE CONNECTOR OF THE DEVICE BROKE DURING USE. THIS HAPPENED OUTSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756922 ↗
• MalfunctionMar 18, 2026Overheating of Device

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE BURR STOPPED WORKING AND DID NOT ROTATE ANYMORE. THE CONSOLE DISPLAYED THE ERROR MESSAGE "HANDPIECE OVERLOADED". REPLACING THE HANDPIECE DID NOT RESOLVE THE PROBLEM; ONLY REPLACING THE BURR SOLVE THE PROBLEM. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 05-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE BURR OVERHEATED. UPDATE 06-MAR-2026 MAJUNG: IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE BURR OVERHEATED AND DID NOT ROTATE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628394 ↗
• MalfunctionFeb 27, 2026Defective Device

  ON 06-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT WHEN A NEW AR-8400OBE 8-FLUTE OVAL BURR WAS ATTACHED, IT WAS UNSTABLE. WHEN THEY REMOVED IT, THE BLADE ATTACHMENT BROKE. THEY OPENED ANOTHER NEW ONE, BUT IT FELT AS IF IT DID NOT HAVE ENOUGH TORQUE, SO THEY GAVE UP ON USING IT. ANOTHER REPLACEMENT WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12-FEB-2026. THE REP ADVISED THAT THEY DO NOT KNOW WHAT PROCEDURE WAS PERFORMED. THEY ADVISED THAT ALL BROKEN FRAGMENTS WERE RETRIEVED, AND NO DUALWAVE OUTFLOW TUBING WAS USED. THE REP THEN STATED THEY DID NOT KNOW IF THERE WAS AN UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE DURING ITS USE, AND THEY DID NOT KNOW IF ANY SHAVER CONSOLES OR HANDPIECES WERE USED WITH THE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470333 ↗
• MalfunctionFeb 27, 2026Break

  ON 06-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT WHEN A NEW AR-8400OBE 8-FLUTE OVAL BURR WAS ATTACHED, IT WAS UNSTABLE. WHEN THEY REMOVED IT, THE BLADE ATTACHMENT BROKE. THEY OPENED ANOTHER NEW ONE, BUT IT FELT AS IF IT DID NOT HAVE ENOUGH TORQUE, SO THEY GAVE UP ON USING IT. ANOTHER REPLACEMENT WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12-FEB-2026. THE REP ADVISED THAT THEY DO NOT KNOW WHAT PROCEDURE WAS PERFORMED. THEY ADVISED THAT ALL BROKEN FRAGMENTS WERE RETRIEVED, AND NO DUALWAVE OUTFLOW TUBING WAS USED. THE REP THEN STATED THEY DID NOT KNOW IF THERE WAS AN UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE DURING ITS USE, AND THEY DID NOT KNOW IF ANY SHAVER CONSOLES OR HANDPIECES WERE USED WITH THE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470167 ↗
• MalfunctionDec 29, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULA (AC) DECOMPRESSION SURGERY THE SHAVER HANDPIECE AR-8332H (SN (B)(6) DAMAGED THE BURR AR-8400OBE (LOT: 15496415). THE BURR GOT TORN UP IN THE BOTTOM WHERE IT WAS CONNECT TO THE SHAVER. PLASTIC PIECES REMAINED IN THE SHAFT OF THE SHAVER HANDPIECE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907104 ↗
• MalfunctionDec 29, 2025Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULA (AC) RESECTION SURGERY THE SHAVER HANDPIECE AR-8332H (SN (B)(6) DAMAGED THE BURR AR-8400OBE (LOT: 15446780). THE BURR GOT TORN UP IN THE BOTTOM WHERE IT WAS CONNECTED TO THE SHAVER. PLASTIC PIECES REMAINED IN THE SHAFT OF THE SHAVER HANDPIECE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905063 ↗
• MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER DECOMPRESSION SURGERY THE SHAVER HANDPIECE AR-8332H (SN: (B)(6)) DAMAGED 2 BURRS AR-8400OBE (BATCH 15446780). THEY GOT TORN UP IN THE BOTTOM WHERE THEY ATTACH TO SHAVER HANDPIECE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618781 ↗
• MalfunctionNov 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER DECOMPRESSION SURGERY THE SHAVER HANDPIECE AR-8332H (SN: (B)(6)) DAMAGED 2 BURRS AR-8400OBE (BATCH 15446780). THEY GOT TORN UP IN THE BOTTOM WHERE THEY ATTACH TO SHAVER HANDPIECE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479101 ↗
• MalfunctionJul 15, 2025Material Fragmentation; Material Fragmentation

  ON 06/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400OBE BURR PRODUCED POWDERED DEBRIS. ALL IRON POWDER HAS BEEN SUCKED UP WITH A SHAVER. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512054 ↗
• MalfunctionMay 28, 2025Material Fragmentation; Material Fragmentation

  ON 05/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400OBE BURR BEGAN TO PRODUCE METAL SHAVINGS WERE SCATTERED THROUGHOUT THE SHOULDER WHILE PERFORMING A RIGHT SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR. THE FACILITY OPENED A SECOND BURR WITH THE SAME LOT NUMBER AND HAVE THE SAME ISSUE. SOLUTION: OPENED A BURR WITH A DIFFERENT LOT NUMBER. THIS OCCURRED DURING USE IN A CASE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22095943 ↗
• MalfunctionMay 28, 2025Material Fragmentation; Material Fragmentation

  ON 05/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400OBE BURR BEGAN TO PRODUCE METAL SHAVINGS WERE SCATTERED THROUGHOUT THE SHOULDER WHILE PERFORMING A RIGHT SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR. THE FACILITY OPENED A SECOND BURR WITH THE SAME LOT NUMBER AND HAVE THE SAME ISSUE. SOLUTION: OPENED A BURR WITH A DIFFERENT LOT NUMBER. THIS OCCURRED DURING USE IN A CASE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22095894 ↗
• MalfunctionOct 29, 2024Material Fragmentation; Material Fragmentation

  ON 10/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT QTY. 2 OF AN AR-8400OBE OVAL BURR HAD AN ISSUE DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024. WHEN TRYING TO USE THE FIRST BURR, IT GOT STUCK IN THE SHAVER HANDPIECE AND COULD NOT BE USED IN THE PROCEDURE. THIS OCCURRED OUTSIDE OF THE PATIENT, AND THEY WERE THEN ABLE TO REMOVE THE BURR FROM THE SHAVER HANDPIECE. THE SECOND BURR PRODUCED METAL DEBRIS IN THE SHOULDER JOINT OF THE PATIENT DURING ITS USE. THE SURGEON WAS ABLE TO REMOVE ALL THE METAL DEBRIS SHAVINGS FROM THE JOINT. AT THAT POINT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE COMPLAINT DEVICES WERE DISCARDED. THIS OCCURRED BEFORE AND DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559349 ↗
• MalfunctionSep 16, 2024Material Fragmentation; Material Fragmentation

  ON 08/30/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS- (B)(4) THAT AN AR-8400OBE SHAVER BURR HAD METAL SHAVINGS COME OUT OF IT WHEN MAKING CONTACT WITH A TIBIAL BONE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223245 ↗
• MalfunctionSep 12, 2024Break; Material Fragmentation; Break; Material Fragmentation

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-8400OBE OVAL BURR HAD AN ISSUE. DURING A DISTAL CLAVICLE EXCISION, A PIECE OF THE FLUTE OF THE BURR GOT CAUGHT IN THE BLADE AND BROKE OFF IN THE PATIENT AND SHATTERED INTO HUNDREDS OF SMALL SHARDS THAT HAD TO BE SHAVEN OUT. MOST SHARDS COULD BE REMOVED WITH A SHAVER, BUT NOT ALL. A SECOND AR-8400OBE OVAL BURR WAS OPENED AFTER, AND THE SAME ISSUE HAPPENED WITH THE 2ND BURR. THE CASE WAS COMPLETED WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR, LABRAM REPAIR, AND DISTAL CLAVICLE EXCISION PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200215 ↗
• MalfunctionSep 12, 2024Break; Material Fragmentation; Break; Material Fragmentation

  ON 08/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-8400OBE OVAL BURR HAD AN ISSUE. DURING A DISTAL CLAVICLE EXCISION, A PIECE OF THE FLUTE OF THE BURR GOT CAUGHT IN THE BLADE AND BROKE OFF IN THE PATIENT AND SHATTERED INTO HUNDREDS OF SMALL SHARDS THAT HAD TO BE SHAVEN OUT. MOST SHARDS COULD BE REMOVED WITH A SHAVER, BUT NOT ALL. A SECOND AR-8400OBE OVAL BURR WAS OPENED AFTER, AND THE SAME ISSUE HAPPENED WITH THE 2ND BURR. THE CASE WAS COMPLETED WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR, LABRAM REPAIR, AND DISTAL CLAVICLE EXCISION PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200169 ↗
• MalfunctionJun 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY, MANY SMALL PIECES OF METAL ¿FLAKES¿ FELL OFF FROM THE BLADE WHEN USING THE BURR (SHAVER BLADE). IT SEEMED THAT THE BLADE SHAVED THE PROTECTION SHIELD. THE SMALL PIECES BROKE OFF INSIDE THE PATIENT BUT ALL PIECES WERE RETRIEVED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19508676 ↗
• MalfunctionJun 3, 2024Material Fragmentation; Material Fragmentation

  ON 11/25/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400OBE BURR CREATED DEBRIS WHILE INSIDE THE PATIENT, AROUND THE ACROMION AREA OF THE SCAPULA. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY ON (B)(6) 2021. ADDITIONAL INFORMATION REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 19446935 ↗
• MalfunctionMay 28, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A SUBACROMIAL DECOMPRESSION (SAD) SURGERY, THE DEVICE GOT SEIZED UP AND DID NOT ROTATE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404619 ↗
• MalfunctionMar 20, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN THE SURGEON USED THE SHAVERBLADE MANY SMALL METAL FLAKES DETACHED FROM THE BLADE IN THE JOINT. THE PARTICLES WERE REMOVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943782 ↗
• MalfunctionMar 8, 2024Break; Break

  ON 2/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT PIECES FROM AN AR- 8400OBE OVAL BURR CAME OFF INTO THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE BROKEN FRAGMENTS. THE SURGEON REPORTED THAT WHILE MANEUVERING THE BURR, A CLICK COULD BE FELT. THE BURR DID NOT COME IN CONTACT WITH THE SCOPE OR ANY OTHER DEVICES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION PROVIDED 3/4/24: THE PROCEDURE PERFORMED WAS AN ANKLE ARTHROSCOPIC PROCEDURE. THE CASE WAS COMPLETED BY OPENING A NEW BURR. NO CASE DELAY. NO ADDITIONAL ANESTHESIA . NO NEGATIVE EFFECTS TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870170 ↗
• MalfunctionOct 9, 2023Material Fragmentation; Material Fragmentation

  ON 9/12/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400OBE BURR HAD AN ISSUE DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023. THE BURR APPEARED TO DEVASTATE/DESTROY UPON CONTACT WITH THE BONE, CAUSING DEBRIS TO BE VISIBLE TO THE ARTHROSCOPE. THE BURR DID NOT BREAK, ONLY ITS TEETH SHED DEBRIS. THE DEVICE WAS DISCARDED BY THE FACILITY. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/22/2023, THE ARTHREX SUBSIDIARY EMPLOYEE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A KNEE ARTHROSCOPY PROCEDURE. THE BURR WAS NO LONGER NEEDED AFTER THE ROUGHING. THE DEBRIS WAS COMPLICATED TO COLLECT SINCE THEY WERE VERY FINE PIECES. IT WAS HOPED THAT AFTER VACUUMING, MOST OF THOSE TINY PIECES THAT LOOKED LIKE DUST WERE REMOVED. DUALWAVE OUTFLOW TUBING WAS NOT USED, AND THERE WAS A CONSTANT, UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE DURING ITS USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A CASE DELAY OF APPROXIMATELY 5 MINUTES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17897644 ↗
• MalfunctionJul 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANKLE JOINT ARTHROSCOPY BROWN PARTICLES WERE IDENTIFIED DURING THE PROCEDURE. THE DEBRIS WAS FLUSHED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267119 ↗
• MalfunctionJun 9, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8400OBE OVAL BURR PRODUCED METAL SHAVING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER. ADDITIONAL INFORMATION RECEIVED ON 5/22/2023. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ELBOW PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17098020 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN AC RESECTION DURING SUTURING OF THE ROTATOR CUFF, THE TIP/BURR OF THE DEVICE FELL OFF. THE SURGEON DID A SEMI-OPEN SURGERY, SO THE BROKEN-OFF BURR COULD BE RETRIEVED WITHOUT CONSEQUENCES. THERE WAS NO HARM TO THE PATIENT, OPERATOR, OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565288 ↗