MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT, NAV 22/61; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023365
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, trial shattered inside the patient when being used.No delay was recorded and no backup was available but same device used.
Additional Manufacturer Narrative
A polarcup trial insert, nav 22/61 was reported due to damaged or broken component.It was reported that the incidence occured during surgery.The device, used in treatment, was returned for evaluation.The visual inspection confirms the reported failure mode, the complaint device is fractured and 3 pieces broke off.Review of the production documentation did not find any deviation from standard operating procedure which could explain the reported failure.The complaint history review did not reveal other complaints concerning devices of the reported batch.Based on the conducted investigation, the root cause of the failure could not be determined conclusively.Further investigations have been initiated to better understand the issue.Smith+nephew will continue to monitor for similar issues.

• Brand Name: POLARCUP TRIAL INSERT, NAV 22/61
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9450788
• Report Number: 9613369-2019-00102
• Device Sequence Number: 2114305
• Product Code: LXH
• UDI-Device Identifier: 07611996112542
• UDI-Public: 07611996112542
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• 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): 02/10/2020

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: No Information
• Device Model Number: 75023365
• Device Catalogue Number: 75023365
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1