MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT SLOTTED 28/49; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000665
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that during a thr procedure the polarcup trial insert slotted 28/49 broke inside the patient.It is not known if all pieces were recovered from the wound and how this procedure was completed.Surgery was delayed for no more than 30 min.
Additional Manufacturer Narrative
Results of investigation: a polarcup trial insert slotted 28/49 (art.No.75000665 / lot number b70391) was reported as broken inside the patient.Surgery was delayed for no more than 30 min.The complaint device, used in treatment, was returned for investigation.The device was found broken, the reported failure mode was confirmed upon visual inspection.The complaint history review were performed, no further complaints for devices from the same lot were found.The production documentation were reviewed, there were no deviations from the standard manufacturing procedure.The ifu (lit.No.12.23 ed 05/16) requires "before use, the functionality of surgical instruments should be checked." all reusable instruments be routinely inspected for wear and damage and replaced as necessary according to the processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19).A review of the risk management documentation verifies the failure mode and severity of the reported issue.For the medical investigation, adequate documentation was not received to fully evaluate the complaint.Based on the conducted investigation, the root cause could not be determined conclusively.No further actions are deemed necessary at the time.Smith+nephew will continue to monitor for similar issues.The device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT SLOTTED 28/49
• 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: 10912882
• Report Number: 9613369-2020-00247
• Device Sequence Number: 19641144
• Product Code: LXH
• UDI-Device Identifier: 07611996116793
• UDI-Public: 07611996116793
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 75000665
• Device Catalogue Number: 75000665
• Device Lot Number: B70391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 11/27/2020
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1