Arthrex® AR-600LRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867110946), received between Aug 31, 2023 and Jun 10, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY THE BACK PART OF THE DEVICE BECAME HOT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 11-APR-2022: IT WAS CONFIRMED THAT THE ERROR OCCURRED ON THE 04-APR-2022 DURING A HIP SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499425 ↗
• MalfunctionMay 9, 2024Break; Break

  ON 04/16/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT A QTY. 2 OF AR-600L BATTERY PACK HOUSINGS WERE COMPLETELY SPLIT AND APART. THIS WAS DISCOVERED WHILE TRYING TO REMOVE BATTERIES FROM THE BATTERY HOUSING DURING AN ACL REPAIR PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280446 ↗
• MalfunctionMay 9, 2024Break; Break

  ON 04/16/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS (B)(4) THAT A QTY. 2 OF AR-600L BATTERY PACK HOUSINGS WERE COMPLETELY SPLIT AND APART. THIS WAS DISCOVERED WHILE TRYING TO REMOVE BATTERIES FROM THE BATTERY HOUSING DURING AN ACL REPAIR PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19275354 ↗
• MalfunctionMay 8, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS (B)(4) THAT A QTY. 2 OF AR-600L BATTERY PACK HOUSINGS WERE COMPLETELY SPLIT AND APART. THIS WAS DISCOVERED WHILE TRYING TO REMOVE BATTERIES FROM THE BATTERY HOUSING DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2024. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274878 ↗
• MalfunctionMay 8, 2024Break; Break

  ON 04/16/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06541011 THAT A QTY. 2 OF AR-600L BATTERY PACK HOUSINGS WERE COMPLETELY SPLIT AND APART. THIS WAS DISCOVERED WHILE TRYING TO REMOVE BATTERIES FROM THE BATTERY HOUSING DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2024. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274642 ↗
• MalfunctionApr 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 2/26/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-600L BATTERY PACK HOUSING WAS COMPLETELY SPLIT AND APART. THIS WAS DISCOVERED AFTER A SHOULDER SCOPE WITH A LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19144566 ↗
• MalfunctionApr 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4 )THAT AN AR-600L BATTERY PACK HOUSING WAS COMPLETELY SPLIT AND APART. THIS WAS DISCOVERED AFTER A FRACTURE PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19143180 ↗
• MalfunctionApr 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 2/26/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-600L BATTERY PACK HOUSING WAS COMPLETELY SPLIT AND APART. THIS WAS DISCOVERED AFTER A SHOULDER SCOPE WITH A LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19142507 ↗
• MalfunctionApr 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE HOUSING IS RUPTURED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142245 ↗
• MalfunctionApr 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE HOUSING IS RUPTURED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142188 ↗
• MalfunctionMar 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-600L BATTERY PACK HOUSING WAS COMPLETELY SPLIT AND APART. THIS WAS DISCOVERED AFTER A SHOULDER SCOPE WITH A LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18987884 ↗
• MalfunctionOct 26, 2023Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  ON 9/29/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(6) THAT AN AR-600L BATTERY PACK HOUSING WAS SPLIT ALONG THE SEAMS. THIS WAS DISCOVERED DURING THE BATTERY REMOVAL AFTER THE CASE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011854 ↗
• MalfunctionAug 31, 2023Crack; Crack

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-600L BATTERY PACK HAS A CRACK ON THE HOUSING. IT WAS INVOLVED IN A CASE. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662314 ↗