MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL RT; PROSTHSIS, KNEE, FEMOROTIBIAL, SMI-CONSTRAIND, CEMENTED, METAL/POLYM

Model Number 71441137

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the knob broke off after the surgeon attached it to the remainder of the jig system.A 0-30 min delay was reported.

Manufacturer Narrative

The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.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.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, the reported event could not be confirmed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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 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.

• Brand Name: GII MI IN SLT 3 MO TI CU BL RT
• Type of Device: PROSTHSIS, KNEE, FEMOROTIBIAL, SMI-CONSTRAIND, CEMENTED, METAL/POLYM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9349650
• MDR Text Key: 167224974
• Report Number: 1020279-2019-04094
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010484093
• UDI-Public: 03596010484093
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2020

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
• Device Operator: Health Professional
• Device Model Number: 71441137
• Device Catalogue Number: 71441137
• Device Lot Number: 05CM13460
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 01/27/2020
• Supplement Dates FDA Received: 12/19/2019; 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1