MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD IMPACTOR; PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR

Model Number 71364009

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2020

Event Type  malfunction  

Event Description

It was reported that the femoral head impactor was broken.It did not occur during procedure, no patient was involved.No other complications were reported.

Manufacturer Narrative

H3, h6: the device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the silicone tip is missing from the femoral head impactor.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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: FEMORAL HEAD IMPACTOR
• Type of Device: PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10177369
• MDR Text Key: 195931520
• Report Number: 1020279-2020-02638
• Device Sequence Number: 1
• Product Code: MBH
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2020
• 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: 17GM12158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1