Arthrex® AR-9530S-03Recalls & reported problems
Arthrex, Inc. · UNIVERS REVERS TRIAL 36 +3 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867062146), received between Nov 7, 2022 and Jul 27, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Break” (11 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.
Reports received per month
Most reported problems
Device problems
- Break11
- Naturally Worn4
- Sharp Edges4
- Dent in Material3
- Activation Problem1
- Crack1
- Defective Device1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036725 ↗MalfunctionDec 31, 2025Use of Device Problem; Use of Device Problem
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-03 UNIVERS REVERS TRIAL PLASTIC COULD NOT WITHSTAND INSERTION. 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 23935636 ↗MalfunctionAug 20, 2025Break; Break
ON 08/04/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9530S-03 UNIVERS REVERSE TRIAL BROKE DURING A CASE. THE INSTRUMENT WAS USED CORRECTLY, BUT THE SMALL HOLES INSIDE THE TRIAL MALFUNCTIONED DUE TO NORMAL WEAR AND TEAR. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE IMPACT, AND NO EXTRA TIME WAS ADDED TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22849442 ↗MalfunctionJul 22, 2025Break; Sharp Edges; Break; Sharp Edges
ON 07/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 4) OF AN AR-9530S-03 UNIVERS REVERS TRIAL WERE BROKEN, SHARP IN THE HOLES WHERE YOU PLACE THE INSTRUMENT TO SQUEEZE THEM. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22569517 ↗MalfunctionJul 22, 2025Break; Sharp Edges; Break; Sharp Edges
ON 07/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 4) OF AN AR-9530S-03 UNIVERS REVERS TRIAL WERE BROKEN, SHARP IN THE HOLES WHERE YOU PLACE THE INSTRUMENT TO SQUEEZE THEM. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22569516 ↗MalfunctionJul 22, 2025Break; Sharp Edges; Break; Sharp Edges
ON 07/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 4) OF AN AR-9530S-03 UNIVERS REVERS TRIAL WERE BROKEN, SHARP IN THE HOLES WHERE YOU PLACE THE INSTRUMENT TO SQUEEZE THEM. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22569492 ↗MalfunctionJul 22, 2025Break; Sharp Edges; Break; Sharp Edges
ON 07/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. (B)(4) OF AN AR-9530S-03 UNIVERS REVERS TRIAL WERE BROKEN, SHARP IN THE HOLES WHERE YOU PLACE THE INSTRUMENT TO SQUEEZE THEM. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22569467 ↗MalfunctionMay 28, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06878076 THAT AN AR-9530S-03 TRIAL SPLIT IN HALF WHEN COMPRESSED WITH A HEMOSTAT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095963 ↗MalfunctionMar 27, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) A FAILURE OF THE DEVICE AR-9530S-03 OCCURRED, WHICH WAS NOT SPECIFIED. NO PART OF THE DEVICE BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708778 ↗MalfunctionMar 21, 2025Break; Break
IT WAS REPORTED THAT DURING AN INVERS SHOULDER SURGERY THE TRIAL WAS DAMAGED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21663488 ↗MalfunctionMar 6, 2025Break; Break
ON 02/20/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9530S-03 TRIAL HUMERAL INSERT 36 +3 WAS DAMAGED. THIS OCCURRED DURING A CASE AND IS NO LONGER USABLE.
Patient problems: Insufficient Information
MAUDE report 21536818 ↗MalfunctionFeb 7, 2025Break; Crack; Break; Crack
ADDITIONAL INFORMATION WAS RECEIVED ON 02/12/2025: THERE WERE NO PHOTOS TAKEN OF THE ISSUE. THE SAME PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA TO THE CASE. THIS OCCURRED DURING A RTSA PROCEDURE ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334884 ↗MalfunctionSep 4, 2024Naturally Worn; Naturally Worn
ON 08/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS(B)(4) THAT AN AR-9530S-03 ARTHREX UNIVERS REVERS, TRIAL HUMERAL INSERT WAS WORN. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140233 ↗MalfunctionAug 12, 2024Break; Break
IT WAS REPORTED THAT DURING AN UNIVERS REVERS IMPLANT SURGERY THE TRIAL INLAY BROKE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT THE TRIAL INILAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19962809 ↗MalfunctionMay 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-03 TRIAL HAD AN ISSUE BEING REMOVED. THE WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. REP CONTACTED ON 9/17 FOR MORE INFO. ADDITIONAL INFORMATION: REP RETURNED CONTACT 9/17, CONFIRMED PROCEDURE DATE AS (B)(6) 2021. STATED THE HOLES IN THE TRIAL WERE WORN, PREVENTING THE HEMOSTATS FROM REMOVING THE TRIAL. THE TRIAL WAS REMOVED USING A FREER ELEVATOR. THE CASE WAS COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19312954 ↗MalfunctionMar 28, 2024Naturally Worn; Naturally Worn
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9530S-03 ARTHREX UNIVERS REVERS TRIAL HUMERAL INSERT IS WORN OUT. IT NO LONGER CLIPS INTO THE CUP, AND IT HAS LOST COMPRESSION. THIS WAS DISCOVERED DURING A PROCEDURE; THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18992962 ↗MalfunctionMar 26, 2024Naturally Worn; Naturally Worn
ON 03/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ARTHREX UNIVERS REVERS HUMERAL INSERT TRIAL WAS WORN. THIS WAS DISCOVERED DURING A PROCEDURE. THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION RECEIVED ON 3/12/2024: THE TRIAL IS PART NUMBER AR-9530S-03 ARTHREX UNIVERS REVERS TRIAL HUMERAL INSERT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18981671 ↗MalfunctionMar 7, 2024Dent in Material; Dent in Material
ON 02/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-03 WAS DENTED/DAMAGED. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857371 ↗MalfunctionMar 6, 2024Dent in Material; Dent in Material
ON 02/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-03 TRIAL HUMERAL INSERT WAS DENTED/DAMAGED. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18848047 ↗MalfunctionMar 6, 2024Dent in Material; Dent in Material
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06487770 THAT AN AR-9530S-03 WAS DENTED/DAMAGED. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18846583 ↗MalfunctionJan 30, 2024Naturally Worn; Naturally Worn
ON 1/8/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-03 UNIVERS REVERS TRIAL WAS DAMAGED THROUGH WEAR AND TEAR. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18608263 ↗MalfunctionNov 6, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING AN UNIVERS REVERS SHOULDER PROSTHESIS SURGERY THE DEVICE PRODUCED DEBRIS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE NROE 17-OCT-2023: FURTHER INFORMATION REVEALED THAT ALL BROKEN-OFF PIECES COULD BE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18072460 ↗MalfunctionNov 7, 2022Break; Activation Problem
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9530S-03 TRIAL HUMERAL INSERT BROKE THROUGH THE HOLES, NOT ALLOWING US TO INSERT THE LINER. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15743519 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page