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Arthrex® AR-8332HRecalls & reported problems

Arthrex, Inc. · SHAVER HP, SYNERGY, HANDCONTROL · Class 1

Quick summary

This Arthrex Synergy shaver handpiece is a powered surgical instrument used to shave bone and tissue during orthopedic procedures. The 65 reports mostly describe the handpiece overheating, cords and wiring splitting or being cut, and positioning failures. There are no deaths and no injuries. No recalls name this device. Reports of these malfunctions rose from 2 in the earlier 12-month period to 17 in the most recent 12 months.

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
66
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00888867123991), received between Mar 14, 2022 and Sep 16, 2026 — classified as 66 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (16 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

Nov 2023: 3 reportsDec 2023: 2 reportsJan 2024: 5 reportsFeb 2024: 3 reportsMar 2024: 2 reportsApr 2024: 4 reportsMay 2024: 6 reportsJun 2024: 5 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 2 reportsJan 2026: 1 reportsFeb 2026: 2 reportsMar 2026: 2 reportsApr 2026: 4 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 4 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device16
  • Material Split, Cut or Torn10
  • Use of Device Problem5
  • Defective Device4
  • Excessive Heating4
  • Positioning Failure4
  • Material Separation3
  • Physical Resistance/Sticking3

Patient problems

  • No Clinical Signs, Symptoms or Conditions60
  • Insufficient Information7
  • Laceration(s)1

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 16, 2026Material Frayed

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50788198 ↗
  • MalfunctionAug 31, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50519549 ↗
  • MalfunctionAug 12, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50225141 ↗
  • MalfunctionAug 4, 2026Material Separation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50128367 ↗
  • MalfunctionAug 4, 2026Material Separation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50128250 ↗
  • MalfunctionApr 16, 2026Overheating of Device

    ON 27-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8332H SHAVER HANDPIECE IS OVERHEATING. THIS ISSUE WAS DISCOVERED WITH NO CASE INVOLVEMENT.

    Patient problems: Insufficient Information

    MAUDE report 24896493 ↗
  • MalfunctionApr 16, 2026Material Split, Cut or Torn

    ON 27-MAR-2026, A FACILITIES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8332H SHAVER HANDPIECE HAS A CUT IN THE CORD. THIS ISSUE WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24895493 ↗
  • MalfunctionApr 9, 2026Material Separation

    ON 19-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8332H SHAVER HAD EXPOSED WIRES AT THE BASE. A CASE WAS INVOLVED WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24833076 ↗
  • MalfunctionApr 9, 2026Material Split, Cut or Torn

    ON 18-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8332H SHAVER HANDCONTROL HAD A CUT IN THE CORD. THIS WAS DISCOVERED DURING A CASE WITH NO ADVERSE EFFECTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24832735 ↗
  • MalfunctionMar 16, 2026Material Split, Cut or Torn

    ON (B)(6), A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT THE AR-8332H SHAVER HANDPIECE HAS A SLICE IN THE CORD. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24606044 ↗
  • MalfunctionMar 5, 2026Positioning Failure; Use of Device Problem

    ON 12-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8332H SHAVER HANDPIECE IS HAVING ISSUES PLACING A BLADE INSIDE. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24519155 ↗
  • MalfunctionFeb 26, 2026Positioning Failure; Use of Device Problem

    ON 04-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8332H SHAVER IS NOT SNAPPING INTO PLACE PROPERLY. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFO PROVIDED 25-FEB-26: ISSUE OCCURRED IN THE SURGICAL FIELD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24454790 ↗
  • MalfunctionFeb 26, 2026Positioning Failure

    ON 04-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8332H SHAVER IS NOT SNAPPING INTO PLACE PROPERLY. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFO PROVIDED 25-FEB-26: ISSUE OCCURRED IN THE SURGICAL FIELD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24454706 ↗
  • MalfunctionJan 19, 2026Electrical /Electronic Property Problem

    ON 31-DEC-2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8332H SHAVER HANDPIECE HAD AN ELECTRICAL ISSUE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24110517 ↗
  • MalfunctionDec 29, 2025Use of Device Problem; Connection Problem; Use of Device Problem; Connection Problem

    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 23907105 ↗
  • MalfunctionDec 29, 2025Use of Device Problem; Use of Device Problem

    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 23904997 ↗
  • MalfunctionNov 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

    ON 10/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8332H SHAVER HAS AN UNKNOWN OBJECT STUCK INSIDE THE HANDPIECE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23619777 ↗
  • MalfunctionNov 21, 2025Use of Device Problem; Use of Device Problem

    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 23619003 ↗
  • MalfunctionMay 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    ON 04/24/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8332H SYNERGY SHAVER CORD WAS CUT. THE CASE INVOLVEMENT IS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 22012445 ↗
  • MalfunctionFeb 12, 2025Unintended Movement; Unintended Movement

    ON 01/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8332H SHAVER HANDPIECE WOBBLED WHEN IN USE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21366775 ↗
  • MalfunctionSep 17, 2024Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT DURING A KNEE JOINT ARTHROSCOPY THE DEVICE WAS DIFFICULT TO LOCK AND DID NOT GIVE THE SAME PERFORMANCE DURING SURGERY. 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 20238616 ↗
  • MalfunctionSep 10, 2024Material Deformation; Material Deformation

    ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06641198 THAT AN AR-8332H SHAVER HAS EXPOSED WIRING ON THE CABLE. DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20181646 ↗
  • MalfunctionJul 18, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT THE SHAVER HAS A LOOSE CONTACT. 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 19773078 ↗
  • MalfunctionJun 24, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

    ON 05/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8332H SHAVER WAS FOUND WITH BIO-BURDEN IN THEM. DISCOVERED IN CASE, PATIENT NOT AFFECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19593752 ↗
  • MalfunctionJun 21, 2024Environmental Particulates; Environmental Particulates

    ON 05/28/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8332H SHAVER WAS FOUND WITH BIO-BURDEN IN THEM. DISCOVERED IN CASE, PATIENT NOT AFFECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19588856 ↗

Other INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.