MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROFIX 750 GRAMS MALLET; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number 71512452

Device Problem Material Deformation (2976)

Patient Problem Not Applicable (3189)

Event Date 01/29/2020

Event Type  malfunction  

Event Description

It was reported that the plastic threads on the mallet were found stripped during surgery.There was no delay in the case.A competitor device was used to complete the procedure.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms that the threads on the caps are damaged causing the cap to disassemble from the mallets.This failure mode has been previously identified.A design change has been implemented to reduce/eliminate this failure mode from recurrence.This device was manufactured prior to the changes being implemented.This instrument exhibits signs of significant use and wear.The device was manufactured in 2013.A review of complaint history on the listed part revealed no prior complaints 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.Design specification insufficient 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.

• Brand Name: PROFIX 750 GRAMS MALLET
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9716816
• MDR Text Key: 182352508
• Report Number: 1020279-2020-00570
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 03596010223890
• UDI-Public: 03596010223890
• Combination Product (y/n): N
• 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: 04/21/2020

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: 71512452
• Device Catalogue Number: 71512452
• Device Lot Number: 13MM00486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1