MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S1-2 11; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71430402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ps trial broke while trailing.This was discovered during a tka.It is unknown if a delay was associated to the failure.It is unknown if a backup device was available.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.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 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 actions are being taken at this time.

• Brand Name: GII PS HI FLEX ISRT TR S1-2 11
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9776417
• Report Number: 1020279-2020-00754
• Device Sequence Number: 11155033
• Product Code: JWH
• UDI-Device Identifier: 03596010493026
• UDI-Public: 03596010493026
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 71430402
• Device Catalogue Number: 71430402
• Device Lot Number: 10LM12040
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1