MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP IMPACTOR HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023345
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr procedure, the pin preventing the from the polarcup impactor handle rotating has broken off outside of the patient, and needs to be replaced.No pieces fell into the patient.Procedure finished with an s+n backup device.
Additional Manufacturer Narrative
It was reported that during a thr procedure, the pin preventing the impactor head of the polarcup impactor handle (75023345) from rotating has broken off outside of the patient and needs to be replaced.The device use in treatment was returned for investigation.The reported issue could be confirmed upon visual inspection.The pin is observed to be fractured.The whole device shows major sign of use, such as dents and scratches.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process.There is no indication that the device failed to match specification at the time of manufacturing.Based on the conducted investigation the root cause is attributed to a component failure without any design or manufacturing related issues.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor the device for similar issues.The returned device will be discarded.

• Brand Name: POLARCUP IMPACTOR HANDLE
• 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: 10678660
• Report Number: 9613369-2020-00207
• Device Sequence Number: 3162187
• Product Code: LXH
• UDI-Device Identifier: 07611996112344
• UDI-Public: 07611996112344
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/07/2020

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: 75023345
• Device Catalogue Number: 75023345
• Device Lot Number: A77941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1