MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT SLOTTED 28/49; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000665
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the polarcup trial insert slotted 28/49 broke.Surgery had been completed with the same device so it was not delayed.The patient was not harmed.
Additional Manufacturer Narrative
A polarcup trial insert slotted 28/49 (art.No.75000665 / lot no.A62450) was reported as broken.Surgery had been completed with the same device.No delay of the surgery or patient harm was reported.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 in two pieces.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 hints 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 SLOTTED 28/49
• 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: 10437674
• Report Number: 9613369-2020-00160
• Device Sequence Number: 14476293
• Product Code: LXH
• UDI-Device Identifier: 07611996116793
• UDI-Public: 07611996116793
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 75000665
• Device Catalogue Number: 75000665
• Device Lot Number: A62450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1