PIVOTPOST REPLACEMENT
Received Oct 11, 2023 · Event occurred Sep 13, 2023
Report 1220246-2023-08140 · MDR key 17914730
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
PIVOTPOST REPLACEMENTCatalog number
AR-1560-02
Lot number
012144
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Additional Manufacturer Narrative
COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-1560-02 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT CONDUCTED DUE TO THE DAMAGE TO THE INSTRUMENT'S ROTATION LEVEL BEING BROKEN OFF. VISUAL EVALUATION NOTED THAT THE ROTATION LEVER WAS BROKEN OFF. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO THE DAMAGE TO THE DEVICE. REFER TO INVESTIGATION PHOTOS.
Additional Manufacturer Narrative
**UDI RELATED DATA QUALITY UPDATES ONLY** UPDATED INFORMATION IN D4 FOR CORRECT UDI (B)(4).
Additional Manufacturer Narrative
COMPLAINT CONFIRMED. ONE UNPACKAGED AR-1560-02 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT CONDUCTED DUE TO THE DAMAGE TO THE INSTRUMENT'S ROTATION LEVEL WAS BROKEN OFF. VISUAL EVALUATION NOTED THAT THE ROTATION LEVER WAS BROKEN OFF. THE REPORTED CONDITION IS MOST LIKELY CAUSED BY OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING.
Description of Event or Problem
ON 9/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06030096 THAT AN AR-1560-02 PIVOTPOST REPLACEMENT SNAPPED OFF DURING A CASE. THE CLIP BROKE OFF TO WHERE IT IS UNUSABLE, AS IT WILL NOT PIVOT AT ALL. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.