MAUDE Adverse Event Report: SYNTHES (USA) LLC GUIDE BLOCK; GUIDE, SURGICAL, INSTRUMENT

Model Number 03.1113.501

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/02/2021

Event Type  malfunction  

Event Description

Depuy synthes 02.111.531 distal radius plate and 03.1113.501 guide block was implanted, malfunctioned, removed and replaced on (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: GUIDE BLOCK
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES (USA) LLC
• MDR Report Key: 12253858
• MDR Text Key: 264543970
• Report Number: MW5102880
• Device Sequence Number: 2
• Product Code: FZX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/28/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 03.1113.501
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR