MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71364009

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

It was reported that during set up/inspection the femoral head impactor tip was found in two pieces.No case related therefore no patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the black femoral head is fractured into two pieces.Both pieces were returned with the device.This device shows signs of significant wear/usage.This device was manufactured in 2011.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FEMORAL HEAD IMPACTOR
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10511319
• MDR Text Key: 206284368
• Report Number: 1020279-2020-04490
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010199256
• UDI-Public: 03596010199256
• 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
• Report Date: 09/18/2020

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: 71364009
• Device Catalogue Number: 71364009
• Device Lot Number: 11DM02151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/12/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1