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

Model Number	75017089
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr the blue nipple plastic part of the polarcup head/liner inserter broke off.Instruments outside the patient.The procedure was completed without delay using same device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr the blue nipple plastic part of the polarcup head/liner inserter (75017089) broke off.The procedure was completed without delay using same device.No patient injury or other complications were reported.The device use in treatment was returned for investigation.However, a visual inspection could not confirm the reported damage since the component reported for breakage was missing on the returned device.A review of the complaint history revealed one additional complaint reported for the batch in question.However, a batch size of 1000 pieces was produced.The additional complaint is 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 component reported for breakage was not returned with the device, the root cause of the reported issue cannot be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• 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: 11612238
• Report Number: 9613369-2021-00141
• Device Sequence Number: 19622207
• Product Code: LXH
• UDI-Device Identifier: 07611996103151
• UDI-Public: 07611996103151
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 75017089
• Device Catalogue Number: 75017089
• Device Lot Number: F71731
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1