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

Catalog Number	57S02025
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem 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
• Common Device Name: 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: 19086078
• Report Number: 3010667733-2024-00198
• Device Sequence Number: 12656438
• Product Code: HWR
• UDI-Device Identifier: 00889797056717
• UDI-Public: 00889797056717
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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 Catalogue Number: 57S02025
• Device Lot Number: 1735501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown