MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ARTICULAR INSERTER/EXTRACT; EXTRACTOR

Model Number 71440194

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2020

Event Type  malfunction  

Event Description

It was reported that during a surgery the insert inserter broke causing a scratch on the new insert, all pieces were recovered; the procedure was successfully completed without delay using a back-up device.No other complications were reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirmed the device fractured at the location of the hook feature on the handle.It is likely that the fracture was due to an overload mechanism.An overload fracture can occur if mechanical loads are applied that exceed the strength of the material.The broken piece was not returned for evaluation.The device was manufactured in 2008.The device shows signs of significant wear/usage.A medical investigation was conducted and this case reports that the inserter broke during use.Per email communication, all pieces were recovered and the procedure was successfully completed using a backup instrument, without any delay or patient injury.Since no patient harm is alleged, no further clinical assessment is warranted.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.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GII ARTICULAR INSERTER/EXTRACT
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10623442
• MDR Text Key: 209742724
• Report Number: 1020279-2020-05111
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 03596010214393
• UDI-Public: 03596010214393
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440194
• Device Catalogue Number: 71440194
• Device Lot Number: 08AM04607
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention