Arthrex® AR-9165CDGRecalls & reported problems
Arthrex, Inc. · BASEPLATE IMPACTOR, ASSEMBLY · Class 1
Quick summary
This Arthrex baseplate impactor, a shoulder surgery tool, has 94 reports, all describing malfunctions, with no deaths and no injuries. The reports mostly describe the tool breaking, most often a tip or clip breaking off, and several note no harm to patients. Reports fell from 9 in the prior 12 months to 1 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00888867136731), received between Apr 1, 2021 and Sep 18, 2026 — classified as 101 malfunctions.
The most frequently reported specific device problem is “Break” (90 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.
Reports received per month
Most reported problems
Device problems
- Break90
- Material Twisted/Bent6
- Defective Device5
- Crack2
- Connection Problem1
- Defective Component1
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions86
- Insufficient Information16
Recent adverse event reports
The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826681 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826103 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825052 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824442 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792771 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791976 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791586 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING THE SHOULDER ARTHROPLASTY WITH UNIVERS REVERS MODULAR GLENOID SYSTEM, THE PLASTIC TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25099346 ↗MalfunctionAug 11, 2025Break; Break
ON 07/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9165CDG BASEPLATE IMPACTOR TIP BROKE. THIS WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777152 ↗MalfunctionJul 15, 2025Break; Break
ON 06/19/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9165CDG BASEPLATE IMPACTOR ASSEMBLY IMPACTOR HAD A CIRCLE AT THE TOP THAT BROKE OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22512102 ↗MalfunctionJul 15, 2025Break; Break
ON 06/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9165CDG BASE PLATE IMPACTOR'S BLUE CLIP IS BROKEN. NOTICED DURING A CASE AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22509899 ↗MalfunctionJul 15, 2025Break; Break
ON 06/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9165CDG BASE PLATE IMPACTOR'S BLUE CLIP IS BROKEN. NOTICED DURING A CASE AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22509889 ↗MalfunctionApr 17, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 05/05/2025: DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025, THE INSTRUMENT WAS FOUND TO BE BROKEN BEFORE THE CASE BEGAN. THE BROKEN PIECE WAS LOCATED IN THE TRAY, AND NO FRAGMENTS ENTERED THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT, USING AN AR-9165CDG BASEPLATE IMPACTOR ASSEMBLY. THERE WERE NO REPORTED DELAYS, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE PATIENT'S BONE QUALITY WAS NOTED TO BE HARD, BUT THIS DID NOT AFFECT THE OVERALL OUTCOME. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858995 ↗MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01, (QTY. 4) OF AN AR-9545-T15-02, AR-9545-T15-03 DRIVER SHAFTS AND AN AR-9165CDG BASEPLATE IMPACTOR ASSEMBLY DRIVER ENDS WERE TWISTED. UPON INSERTING THE PERIPHERAL LOCKING SCREWS FOR THE BASEPLATE, THE DRIVER END WOULD TWIST FROM THE TORQUE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21410948 ↗MalfunctionDec 30, 2024Break; Break
ON 12/04/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-9165CDG BASEPLATE IMPACTOR ASSEMBLY DRILL GUIDE AND IMPACTORS HAD DAMAGED TIPS. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036034 ↗MalfunctionDec 30, 2024Break; Break
ON 12/04/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT (QTY. (B)(4)) OF AN AR-9165CDG BASEPLATE IMPACTOR ASSEMBLY DRILL GUIDE AND IMPACTORS HAD DAMAGED TIPS. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036026 ↗MalfunctionNov 5, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 10/28/2024 BY A SALES REPRESENTATIVE WHO STATED THAT THE EVENT OCCURRED ON 10/17/2024. THE PROCEDURE BEING PERFORMED WAS AN RTSA. THE BLUED PIECE OF THE DEVICE BROKE WHILE IMPACTING. NO PHOTOS WERE TAKEN. AN ARTHREX AGENT WAS PRESENT DURING THE PROCEDURE. THE PATIENT'S BONE QUALITY WAS GOOD. A REAMER 1 AND A FINAL REAMER WERE USED TO PREPARE THE BONE SOCKET. AL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT ANY DELAYS OR NEED FOR ADDITIONAL ANESTHESIA.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20612446 ↗MalfunctionOct 11, 2024Break; Break
ON 09/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THREE (QTY.3) AR-9165CDG BASEPLATE IMPACTORS HAVE BROKEN PLASTIC TIPS. NO HARM WAS DONE TO THE PATIENT AND THE CASES FINISHED WITHOUT ANY NEGATIVE IMPACT. REPLACEMENTS WERE USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20426622 ↗MalfunctionOct 9, 2024Break; Break
ON 09/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (B)(4) AR-9165CDG BASEPLATE IMPACTORS HAVE BROKEN PLASTIC TIPS. NO HARM WAS DONE TO THE PATIENT AND THE CASES FINISHED WITHOUT ANY NEGATIVE IMPACT. REPLACEMENTS WERE USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410125 ↗MalfunctionOct 9, 2024Break; Break
ON 09/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THREE (QTY(B)(4) AR-9165CDG BASEPLATE IMPACTORS HAVE BROKEN PLASTIC TIPS. NO HARM WAS DONE TO THE PATIENT AND THE CASES FINISHED WITHOUT ANY NEGATIVE IMPACT. REPLACEMENTS WERE USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410099 ↗MalfunctionJun 18, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY THE PLASTIC TABS OF THE BASE PLATE IMPACTOR BROKE OFF OUTSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19558692 ↗MalfunctionJun 15, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A UNIVERSE REVERSE PROSTHESIS SURGERY THE BLUE PLASTIC OF THE INSERTER FOR THE BASE PLATE CRACKED BUT NOTHING BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19544134 ↗MalfunctionJun 11, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-9165CDG UNIVERS REVERS UNIVERSAL BASEPLATE IMPACTOR BLUE PLASTIC TIPS WAS FOUND TO BE BROKEN AFTER THE CASE, DURING CLEANING FROM AN RTSA PROCEDURE ON (B)(6) 2024. THE ISSUE DID NOT DISRUPT THE CASE OR CAUSE ANY NEGATIVE IMPACT ON THE PATIENT, AND THE CASE WAS COMPLETED AS NORMAL. THIS WAS DISCOVERED AFTER USE, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510967 ↗MalfunctionJun 11, 2024Break; Break
ON 5/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-9165CDG UNIVERS REVERS UNIVERSAL BASEPLATE IMPACTOR BLUE PLASTIC TIPS WAS FOUND TO BE BROKEN AFTER THE CASE, DURING CLEANING FROM AN RTSA PROCEDURE ON (B)(6) 2024. THE ISSUE DID NOT DISRUPT THE CASE OR CAUSE ANY NEGATIVE IMPACT ON THE PATIENT, AND THE CASE WAS COMPLETED AS NORMAL. THIS WAS DISCOVERED AFTER USE, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510930 ↗MalfunctionJun 11, 2024Break; Break
ON 5/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-9165CDG UNIVERS REVERS UNIVERSAL BASEPLATE IMPACTOR BLUE PLASTIC TIPS WAS FOUND TO BE BROKEN AFTER THE CASE, DURING CLEANING FROM AN RTSA PROCEDURE ON (B)(6) 2024. THE ISSUE DID NOT DISRUPT THE CASE OR CAUSE ANY NEGATIVE IMPACT ON THE PATIENT, AND THE CASE WAS COMPLETED AS NORMAL. THIS WAS DISCOVERED AFTER USE, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510908 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.