MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR

Model Number 74018902

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure when implanting the femoral component, one of the tabs of the outer-grip locking fem implant impactor broke off.This happened during use inside the patient.A delay of less than 30 min was reported.S&n back up device was available to complete the procedure.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned impactor confirms one of the tabs broke off the device.The broken piece was not returned with the device.The device shows significant signs of wear/usage.A medical investigation was conducted and this case reports one of the tabs of the outer-grip locking femoral implant impactor broke off during use.Per complaint description, there was a delay of less than 30 minutes, and the procedure was completed with a backup device.Photos of the impactor show the broken tab and impactor.Since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.Should 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: OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR
• Type of Device: IMPACTOR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10604111
• MDR Text Key: 209113513
• Report Number: 1020279-2020-04943
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 00885556697962
• UDI-Public: 00885556697962
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74018902
• Device Catalogue Number: 74018902
• Device Lot Number: 20DM16262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention