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 tool from the operating room of the hospital was borrowed to complete the surgery.A less than 30 min delay was reported.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9932058
• MDR Text Key: 186743952
• Report Number: 1020279-2020-01199
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010223890
• UDI-Public: 03596010223890
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• 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: 17EM05705
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention