Arthrex® AR-1600MRecalls & reported problems
Arthrex, Inc. · 3-POINT SHOULDER DISTRACTION SYSTEM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888867019911), received between Dec 26, 2023 and Mar 5, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break5
- Defective Device5
- Detachment of Device or Device Component3
- Positioning Failure2
- Unintended Movement2
- Component Missing1
- Device-Device Incompatibility1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information4
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Unintended Movement
ON 12-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM WOULD NOT LOCK. WHEN THEY POSITION THE TRACTION TOWER AND TIGHTEN IT INTO PLACE, IT WOULD NOT CATCH, IT DIDN'T TIGHTEN AS IT SHOULD'VE AND THE TENSION LOOSENED. THIS OCCURRED DURING A CASE WITH NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518705 ↗MalfunctionJan 21, 2026Material Twisted/Bent
ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM MAIN POST, THAT CONTROLS THE BOOM ARM WAS SLIGHTLY BENT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130987 ↗MalfunctionJan 8, 2026Positioning Failure
ON 19-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM ARMS WERE TOO LOOSE AND DROPPED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005314 ↗MalfunctionDec 29, 2025Positioning Failure; Positioning Failure
ON 16-DEC-2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM HANDLE THAT TURNS CLOCKWISE TO TURN IT DID NOT HOLD IN PLACE. IT UNSCREWED FURTHER BUT WOULD NOT TIGHTEN UP. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23906911 ↗MalfunctionApr 2, 2025Defective Device; Defective Device
ON 17 MARCH 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM WAS REPORTED TO HAVE THE CABLE BEING TOO LONG. THE CABLE WAS WRAPPED AROUND A POST TO MAKE IT SHORTER. THIS OCCURRED ON (B)(6) 2025 IN STARS DURING A SHOULDER LABRAL REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING THE DEVICE WITH THE CABLE WRAPPED AROUND THE POST TO SHORTEN IT. THERE WAS CASE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21753811 ↗MalfunctionJan 16, 2025Break; Break
ON 12/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM KNOB WAS BROKEN. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21170060 ↗MalfunctionAug 12, 2024Break; Break
ON 07/16/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM CABLE WAS DAMAGED. THE CABLE EYE LOOP BROKE AND WAS NOT WORKING AS INTENDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19961426 ↗MalfunctionJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 06/19/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS- (B)(4) THAT (2) AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEMS CABLES PLASTIC WAS COMING OFF. THIS WAS DISCOVERED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740324 ↗MalfunctionJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 06/19/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS- (B)(4) THAT (2) AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEMS CABLES PLASTIC WAS COMING OFF. THIS WAS DISCOVERED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740237 ↗MalfunctionJun 11, 2024Device-Device Incompatibility; Device-Device Incompatibility
ON 05/04/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M SHOULDER DISTRACTION SYSTEM BAR LATCHES DO NOT FIXATE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THE CASE WAS COMPLETED USING ANOTHER SYSTEM THAT WORKED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19512728 ↗MalfunctionJun 10, 2024Material Frayed; Material Frayed
ON 05/14/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06567605 THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEMS CABLING WAS FRAYING. THIS WAS DISCOVERED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19501876 ↗MalfunctionJun 5, 2024Component Missing; Component Missing
ON 08/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM IS MISSING THE ADJUSTMENT KNOB ON THE BOTTOM. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19468976 ↗MalfunctionMay 24, 2024Break; Break
IT WAS REPORTED THAT THE WIRE ROPE SNAPPED AT THE MIDDLE BAR. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397069 ↗MalfunctionMay 21, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CABLE IS WORN. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19361492 ↗MalfunctionMay 17, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THE BLACK SCREW IS DEFECTIVE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19346484 ↗MalfunctionMay 15, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THE AR-1600M, DISTRACTION SYSTEM WILL NOT LOCK INTO POSITION.
Patient problems: Insufficient Information
MAUDE report 19321552 ↗MalfunctionApr 30, 2024Defective Device; Defective Device
ON (B)(6)2021 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN THE AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM, WILL NOT LOCK IN POSITION. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213579 ↗MalfunctionApr 18, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED BY THE SALES REP THAT DURING CASE PREPARATION, THE AR-1600M, MADE A LOUD SOUND DURING RE-TIGHTEN. THE HANDLE WOULD NO LONGER FULLY TIGHTEN AND WILL ONLY SPIN IN PLACE WITHOUT LOCKING THE ARM FULLY INTO POSITION.
Patient problems: Insufficient Information
MAUDE report 19133767 ↗MalfunctionMar 28, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REP. VIA EMAIL THAT FOR AN AR-1600M, 3-POINT SHOULDER DISTRACTION SYSTEM, THE LATERAL SHOULDER TRACTION UNIT BROKE AS THE WIRE HAD SNAPPED. THIS WAS DETECTED DURING USE IN A SHOULDER ARTHROSCOPIC STABILIZATION PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SPARE TRACTION UNIT AT THE HOSPITAL.
Patient problems: Insufficient Information
MAUDE report 18994716 ↗MalfunctionMar 20, 2024Break; Break
ON 03/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM CABLE WAS BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942768 ↗MalfunctionDec 26, 2023Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component
ON 11/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM LOOKED LIKE THE CRIMP FAILED, THE WEIGHTS HIT THE GROUND AND THE PATIENT'S ARM DROPPED ONTO THE STERILE FIELD. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18395387 ↗
Other Apparatus, traction, non-powered devices
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- NA 357.371Synthes GmbH · APPARATUS, TRACTION, NON-POWERED16 reports
- NA SD393.640Synthes GmbH · APPARATUS, TRACTION, NON-POWERED15 reports
- NA 394.44Synthes GmbH · APPARATUS, TRACTION, NON-POWERED12 reports
- Active Heel Traction Boot 72202682Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED10 reports
- Arthrex® AR-8970JDArthrex, Inc. · Apparatus, traction, non-powered10 reports
- NA 72201725Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED8 reports
- Pivot Guardian 3105000100Stryker Corporation · Apparatus, traction, non-powered6 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.
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