MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROFIX 750 GRAMS MALLET; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number 71512452

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  Injury  

Event Description

It was reported that the platform received the notice of bone hammer disinfection issued by the company, and then it was sterilized in strict accordance with the company's requirements.The polyethylene head end of bone hammer was loosened in varying degrees after several times of disassembly, and it could not be used normally during the operation.No back up was available and a similar tools from the operating room of the hospital was borrowed to complete the surgery.A less than 30 min delay was reported.

Manufacturer Narrative

It was reported that the polyethylene head end of the bone hammer was loosened and it could not be used normally during the operation.A similar tool from the operating room was borrowed to complete the surgery.The associated profix 750 grams mallet, intended to be used for treatment, was returned and evaluated.A visual assessment noted that the threads on the cap are damaged causing the cap to disassemble from the mallet.This failure mode has been previously identified.A design change has been implemented to reduce/eliminate this failure mode from recurrence.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.However, a relationship between the device and the reported incident could be corroborated.This device was manufactured prior to the changes being implemented.The root cause of the reported failure was determined to be a design of the device.No further actions are being taken at this time.We consider this investigation closed.Based on this investigation, the corrective action has previously been implemented.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: PROFIX 750 GRAMS MALLET
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9952334
• MDR Text Key: 187378170
• Report Number: 1020279-2020-01272
• Device Sequence Number: 1
• Product Code: JWH
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71512452
• Device Catalogue Number: 71512452
• Device Lot Number: 17CM02640
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention