MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/57; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023363
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the polarcup trial insert nav 22/57 broke in several pieces.It is not known if it was inside of the patient.Procedure was finished with an s+n backup device.
Additional Manufacturer Narrative
A polarcup trial insert nav 22/57 (art.No.75023363 / lot no.A50667) was reported as broken.The procedure was finished with an s+n backup device.The complaint device, used in treatment, was returned for investigation.The reported failure mode was confirmed upon visual inspection.The complaint part was found broken, 5 slots of the trial insert were fractured and broken off.The complaint device showed significant signs of damage and use.A review of the complaint history revealed no other complaint for the batch in question.A review of the batch record showed no deviations from the standard manufacturing process.There are no indications that the device did not meet the specifications at the time of manufacturing.Based on the conducted investigation, the root cause could not be determined conclusively.No further actions are deemend necessary.Smith+nephew will continue to monitor for similar issues.The complaint device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/57
• 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: 10737961
• Report Number: 9613369-2020-00217
• Device Sequence Number: 19314313
• Product Code: LXH
• UDI-Device Identifier: 07611996112528
• UDI-Public: 07611996112528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2020

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: 75023363
• Device Catalogue Number: 75023363
• Device Lot Number: A50667
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1