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 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
• 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: 9932058
• Report Number: 1020279-2020-01199
• Device Sequence Number: 11494129
• 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
• Report Date (Section B): 09/01/2021

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: 17EM05705
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 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