MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS ART ISRT TRL SZ 1-2 10MM LT; PROSTHESIS/KNEE/PATELLOFEMOROTIBIAL/SEMI-CONSTRAINED/CEMENTED/POLYMER/METAL

Model Number	74035222
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection of a loaner kit in warehouse the part was found broken/ missing/ deformed.The device will not be returned.There was no harm to patient, no delay, and the broken piece was not remain.No case involved.
Additional Manufacturer Narrative
H6: h10: the device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.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 device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY II BCS ART ISRT TRL SZ 1-2 10MM LT
• Common Device Name: PROSTHESIS/KNEE/PATELLOFEMOROTIBIAL/SEMI-CONSTRAINED/CEMENTED/POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10102315
• Report Number: 1020279-2020-01909
• Device Sequence Number: 3514398
• Product Code: JWH
• UDI-Device Identifier: 00885556156780
• UDI-Public: 00885556156780
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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 Model Number: 74035222
• Device Catalogue Number: 74035222
• Device Lot Number: 17BAP0105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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