MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAY/ARTICULAR SURFACE INSERTER BOTTOM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	00584305200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka, the inserter broke while trying to seat the poly.All pieces were retrieved.It is unknown how the procedure was finished.Surgery was not delayed.Patient was not harmed beyond the described event.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirmed one side of the tip is broken off the tray/articular surface inserter tip.The device shows significant signs of wear/usage.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.

• Brand Name: TRAY/ARTICULAR SURFACE INSERTER BOTTOM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10780702
• Report Number: 1020279-2020-06083
• Device Sequence Number: 3772996
• Product Code: LXH
• UDI-Device Identifier: 00885556621653
• UDI-Public: 00885556621653
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/07/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00584305200
• Device Catalogue Number: 00584305200
• Device Lot Number: 60216121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 03/07/2021
• 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: Required Intervention