MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH TIB ALIGN M/L TRANS TUBE; PRSTHSIS,KNEE,PTLFMRTIBL,SMI-CNSTRND,CMNTD,POLYMR/METAL/POLYMER

Catalog Number	71442165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument broke during the surgery.There was no backup device available.No pieces fell into the patient.
Additional Manufacturer Narrative
The associated orthomatch tibial alignment m/l trans tube was not returned for evaluation.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: ORTHOMATCH TIB ALIGN M/L TRANS TUBE
• Common Device Name: PRSTHSIS,KNEE,PTLFMRTIBL,SMI-CNSTRND,CMNTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7866147
• Report Number: 1020279-2018-01798
• Device Sequence Number: 13878922
• Product Code: JWH
• UDI-Device Identifier: 00885556495100
• UDI-Public: 00885556495100
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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 Catalogue Number: 71442165
• Device Lot Number: 16CSY0021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 11/02/2018
• 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