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

Model Number	75017089
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a thr the blue plastic piece of a polarcup head/liner inserter is cracked.Procedure was finished with the same device, no delay reported.No patient harm reported.
Additional Manufacturer Narrative
H3, h6: it was reported during a thr the blue plastic piece of a polarcup head/liner inserter is cracked.Procedure was finished with the same device, no delay reported.No patient harm reported.The complaint device, intended for use in treatment, was not returned for investigation.Hence the reported issue could not be confirmed.Two additional complaints of the same batch were reported so far with a reported failure mode of a broken instrument.However, a batch size of 1000 pieces was produced.The additional two complaints are therefore not an indication for a manufacturing related issue with this batch.A review of the batch record revealed no deviations during 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.Since the complaint device was not returned, the root cause of the reported issue cannot be determined.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.The need for corrective action is not indicated.Should the complaint device become available, the complaint will be reassessed.Smith + nephew will continue to monitor this device for similar issues.

• 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: 12345475
• Report Number: 9613369-2021-00347
• Device Sequence Number: 4536362
• Product Code: LXH
• UDI-Device Identifier: 07611996103151
• UDI-Public: 07611996103151
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: F71731
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1