MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II FEMORAL TRIAL IMPACTOR; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71440468
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the impactor broke during insertion of implant.Delay of almost an hour.Backup device from smith and nephew available.
Additional Manufacturer Narrative
The associated complaint device was not returned.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.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.

• Brand Name: GNS II FEMORAL TRIAL IMPACTOR
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8884098
• Report Number: 1020279-2019-03015
• Device Sequence Number: 14132312
• Product Code: MDM
• UDI-Device Identifier: 03596010215642
• UDI-Public: 03596010215642
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2019

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 Expiration Date: 05/08/2011
• Device Catalogue Number: 71440468
• Device Lot Number: 01DM13923
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 11/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1