MAUDE Adverse Event Report: SYNTHES (USA) PRODUCTS LLC. DEPUY SYNTHES PLATE; PLATE, FIXATION, BONE

Model Number 02 115 350

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/24/2021

Event Type  Injury  

Event Description

My orthopedic dr used a depuy synthes plate # 02 115 350 attach the right distal radius to the ulnar after correction was made.The plate used broke , while the arm was still in the cast.There was a lot of unnecessary pain caused by this brake and had to go through two more surgery's.The plate was removed and i have keep the broken plate in my possession.I looked for any recalls and could not find one for this product.My name is (b)(6).Fda safety report id # (b)(4).

• Brand Name: DEPUY SYNTHES PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA) PRODUCTS LLC.
• MDR Report Key: 15606168
• MDR Text Key: 301933585
• Report Number: MW5112632
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 02 115 350
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: IBUPROFEN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White