MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/51; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023360
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial was found broken in set during set up or inspection.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
Investigation results: it was reported that the polarcup trial insert nav 22/51 (art.No.75023360 / lot no.A61346) was found broken in set during set up or inspection.No surgical delay or injury to the patient was reported.The complaint device, used in treatment, was returned for complaint investigation.The complaint part was found broken in three pieces.A review of the complaint history revealed no other complaint for the batch in question.A review of the batch record showed no deviations from the standard manufacturing process.There are no hints that the device did not meet the specifications at the time of manufacturing.Based on the conducted investigation, the root cause could not be determined conclusively.No further actions are deemed necessary.Smith+nephew will continue to monitor for similar issues.The complaint device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/51
• 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: 11450010
• Report Number: 9613369-2021-00107
• Device Sequence Number: 14465194
• Product Code: LXH
• UDI-Device Identifier: 07611996112498
• UDI-Public: 07611996112498
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75023360
• Device Catalogue Number: 75023360
• Device Lot Number: A61346
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1