MAUDE Adverse Event Report: STRYKER GMBH 6 HOLE FRACTURE PLATE; PLATE, BONE

Model Number 55-15506

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Extracted broken hardware from a patient, felt to be a quality failure per the surgeon.

• Brand Name: 6 HOLE FRACTURE PLATE
• Type of Device: PLATE, BONE
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 16529639
• MDR Text Key: 311220412
• Report Number: MW5115676
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55-15506
• Device Catalogue Number: 55-15506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White