MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II STEMLESS TIB TR SZ 1 LT; PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CMNTD,METAL/POLYMER

Model Number	71430161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device came back from sterilization broken.No case involved.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
The associated device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.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 a manufacturing abnormality 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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: GNS II STEMLESS TIB TR SZ 1 LT
• Common Device Name: PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CMNTD,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10546592
• Report Number: 1020279-2020-04634
• Device Sequence Number: 2992478
• Product Code: HRY
• UDI-Device Identifier: 03596010211385
• UDI-Public: 03596010211385
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2021

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: 71430161
• Device Catalogue Number: 71430161
• Device Lot Number: 19JM20159
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 02/23/2021; 04/29/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 02/23/2021; 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1