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

Model Number	71512452
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2020-01272
• Device Sequence Number: 2333986
• Product Code: JWH
• UDI-Device Identifier: 03596010223890
• UDI-Public: 03596010223890
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71512452
• Device Catalogue Number: 71512452
• Device Lot Number: 17CM02640
• Initial Date Received by Manufacturer: 03/15/2020
• Supplement Date Received by Manufacturer: 03/15/2020; 08/30/2021
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/24/2020; 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention