MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/59; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023364
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thr procedure the polarcup trial insert nav 22/59 broke into many pieces while being used.No injuries or surgical delays reported.Procedure was finished changing the surgical technique.
Additional Manufacturer Narrative
It was reported that during a total hip replacement procedure, the polarcup trial insert nav 22/59 broke into many pieces while being used.No injuries or surgical delays were reported.The procedure was finished, changing the surgical technique.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.6 pieces were broken off the instrument.A review of the batch record showed no deviations from the standard manufacturing process.A review of the complaint history revealed no other complaint for the batch in question.The severity and the failure mode are covered through the smith & nephew risk management.No clinically sufficient data was provided, to perform a medical investigation.Furthermore, the ifu (no.12.23, ed.05/16) refers to the surgical technique for the correct handling of surgical instruments.The functionality of instruments should be checked and using damaged instruments may lead to early failure to implants.However, in this case it is unclear what may have caused the failure mode.To conclude, based on the performed investigations, the root cause of this failure could not be determined.No further actions are deemed necessary.Smith+nephew will continue to monitor this article for similar issues.The returned device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/59
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10679060
• Report Number: 9613369-2020-00209
• Device Sequence Number: 16934487
• Product Code: LXH
• UDI-Device Identifier: 07611996112535
• UDI-Public: 07611996112535
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75023364
• Device Catalogue Number: 75023364
• Device Lot Number: A50268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention