MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S1-2 9; TRAY, SURGICAL, INSTRUMENT

Catalog Number	71430401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tka a piece of the insert broke off inside the patient when placed on the tibial tray trial.All pieces accounted for.No delay or injury reported.Back up was not required.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Our assessment confirmed a piece is broken off the trial.The device shows significant signs of wear/usage.The device was manufactured in 2008.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/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.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT TR S1-2 9
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8062446
• Report Number: 1020279-2018-02432
• Device Sequence Number: 11378203
• Product Code: FSM
• UDI-Device Identifier: 03596010493019
• UDI-Public: 03596010493019
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

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 Catalogue Number: 71430401
• Device Lot Number: 08MM08892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1