MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY LOCKING TIBIAL IMPACTOR; PROSTHESIS,KNEE,PATELLO/FEMOROTIBIAL,SEMI-CONSTRAINED,COATED,POLYMER/METAL

Catalog Number	71935414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure tka, the device was broken outside the patient.The procedure was completed without delay.Backup from smith&nephew was available.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and damaged.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A complaint history review for the listed part revealed no prior complaints for the listed failure with same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.

• Brand Name: JOURNEY LOCKING TIBIAL IMPACTOR
• Common Device Name: PROSTHESIS,KNEE,PATELLO/FEMOROTIBIAL,SEMI-CONSTRAINED,COATED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10131134
• Report Number: 1020279-2020-02168
• Device Sequence Number: 14288337
• Product Code: MBH
• UDI-Device Identifier: 00885556645666
• UDI-Public: 885556645666
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 07/29/2020

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: Other
• Device Catalogue Number: 71935414
• Device Lot Number: 19DM19400
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1