MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP NECK ADAPTOR FOR MONOBLOC STEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75017087
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a tka procedure, the polarcup neck adaptor for monobloc stem broke while impacting.Surgery was finished with a s+n backup device.No information about surgical delays was initially provided.
Additional Manufacturer Narrative
Results of investigation: it was reported that during a total hip arthroplasty procedure, the polarcup neck adaptor for monobloc stem (art.No.75017087 / unknown lot number) broke while impacting.The surgery was finished with a smith+nephew backup device.No information about surgical delays was initially provided.The complaint device, used in treatment, was not returned for investigation.The production documentation and complaint history review could not be performed since the lot number was not provided.The ifu (lit.No.12.23 ed 05/16) requires "before use, the functionality of surgical instruments should be checked." all reusable instruments be routinely inspected for wear and damage and replaced as necessary.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Smith+nephew did not receive adequate documentation to perform the medical investigation.Based on the conducted investigation, the root cause could not be determined conclusively.Internal complaint reference number: (b)(4).

• Brand Name: POLARCUP NECK ADAPTOR FOR MONOBLOC STEM
• 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: 11026995
• Report Number: 9613369-2020-00263
• Device Sequence Number: 13620064
• Product Code: LXH
• UDI-Device Identifier: 07611996098051
• UDI-Public: 07611996098051
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 75017087
• Device Catalogue Number: 75017087
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other