MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FLEX-EXT SPACER 13MM; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	74018613
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an efip inspection the device was found broken.No case involved.
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirms the device fractured into two piece.Both pieces were returned for evaluation.This instrument exhibit signs of significant use and wear.The device was manufactured in 2006.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURNEY FLEX-EXT SPACER 13MM
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10199555
• Report Number: 1020279-2020-02769
• Device Sequence Number: 16380924
• Product Code: JWH
• UDI-Device Identifier: 03596010557131
• UDI-Public: 03596010557131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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,Followup
• Report Date (Section B): 07/30/2020

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: 74018613
• Device Catalogue Number: 74018613
• Device Lot Number: 06BM10313
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020; 07/29/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 06/26/2020; 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1