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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that polarcup head/liner inserter fractured.This was noticed upon inspection of instrument receipt.No information about surgical delays, s+n backup devices or when this incident happened was initially provided.
Additional Manufacturer Narrative
Results of investigation: it was reported that polarcup head/liner inserter (art.No.75017089, lot no.C74206) presented an unspecified failure mode.The complaint part, intended for use in treatment, was received, however 2 inserts of the complaint device were missing.The visual inspection could confirm that one of the plastic component was found fractured and broken in two separate pieces.The complaint history review was performed, no other complaint for devices of the same batch was found.The production documentation was reviewed, no deviations from the standard manufacturing process were found.Based on the conducted investigation, the root cause can not be determined conclusively.There are no indications that the device in question did not confirm the specifications at the time of manufacturing.No further actions are deemed necessary.Smith+nephew will continue to monitor similar issues.The complaint 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: 10754572
• Report Number: 9613369-2020-00220
• Device Sequence Number: 14413140
• Product Code: LXH
• UDI-Device Identifier: 07611996103151
• UDI-Public: 07611996103151
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 75017089
• Device Catalogue Number: 75017089
• Device Lot Number: C74206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1