MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP HEAD/LINER INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75017089
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the plastic of the polarcup head/liner inserter (75017089 ) was found broken. the device use in treatment was returned for investigation.The reported issue could be confirmed upon visual inspection.The linear guide of the head-liner inserter is observed to be fractured alongside the linear groove.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 that could have contributed to the reported issue.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.
Event or Problem Description
It was reported that the plastic of the polarcup head/liner inserter was found broke off.No information about surgical delays or backup devices was initially provided.

• Brand Name: POLARCUP HEAD/LINER INSERTER
• 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: 11646687
• Report Number: 9613369-2021-00149
• Device Sequence Number: 19607364
• Product Code: LXH
• UDI-Device Identifier: 07611996103151
• UDI-Public: 07611996103151
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/11/2021

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: 75017089
• Device Catalogue Number: 75017089
• Device Lot Number: E69822
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 04/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1