MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Model Number 71360093

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

It was reported that the femoral head/neck impactor was found to be broken during a routine efip inspection.There were no reported problems from any cases.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the femoral head is missing from the device.The femoral head was not returned with the device.This device shows signs of significant wear/usage.This device was manufactured in 2012.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.

• Brand Name: FEMORAL HEAD/NECK IMPACTOR
• Type of Device: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10480191
• MDR Text Key: 205245593
• Report Number: 1020279-2020-04357
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010619310
• UDI-Public: 03596010619310
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71360093
• Device Catalogue Number: 71360093
• Device Lot Number: 12LM13553
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1