MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC DRIVER HEX 2.5MM STERILE MICA SCREW SYSTEM; DRIVER, PROSTHESIS

Catalog Number 57S02025

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the sterile packed mica 2.5 hex drivers shattered inside patient while attempting to remove a screw.Two drivers broke and stripped the threads inside of screw head, a 3rd driver was used to advance a separate screw forward with no issues.The patient was booked for removal of hardware, hardware was unable to be removed and is still impinging upon soft tissues.Incision site was opened significantly and bone around implant was carved out in attempt to retrieve head with no success.Case lasted much longer than anticipated due to these issues.

• Brand Name: DRIVER HEX 2.5MM STERILE MICA SCREW SYSTEM
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19086077
• MDR Text Key: 339877045
• Report Number: 3010667733-2024-00199
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 00889797056717
• UDI-Public: 00889797056717
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 57S02025
• Device Lot Number: 1764948
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention