MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTHESISHIPSMICONSTRAINDUNCMNTDMETALPOLYMERNONPOROUSCALICUMPHOSPHAT

Model Number 71360093

Device Problem Fracture (1260)

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

Event Date 03/13/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, tip broke off.All pieces were removed from the patient.There was no harm to the patient or staff.There was no substantial procedural delay.There was a back up that was used to complete the case.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The plastic impactor bumper on the device fractured into multiple pieces and not all of the pieces were returned.The device was manufactured in 2015 and shows signs of extensive wear/usage.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.

• Brand Name: FEMORAL HEAD/NECK IMPACTOR
• Type of Device: PROSTHESISHIPSMICONSTRAINDUNCMNTDMETALPOLYMERNONPOROUSCALICUMPHOSPHAT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9875614
• MDR Text Key: 184808510
• Report Number: 1020279-2020-01004
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

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: 71360093
• Device Catalogue Number: 71360093
• Device Lot Number: 15AM08065
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1