MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100; SMOOTH FIXATION PIN

Model Number IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Osteolysis (2377)

Event Date 02/21/2024

Event Type  Injury  

Event Description

On 02/21/2024, it was reported by a sales representative via (b)(4) that a doctor is having an issue with the ar-4152ds trim-it drill pin system.The arthrex rep was just made aware of three patients who experienced osteolysis (bone loss) post-op after having hand or carpel bone wrist procedures from 2021 to 2023.No specific patient information was made available at this time.Additional information 3/12/2024: this doctor no longer works in our footprint, and i¿m unsure if he is still operating.It was his old pa who is now inquiring about it.The previous doctor's surgery was a scapholunate reconstruction, and then he would throw a couple of the ar-4152ds wires to hold stability.The pa said that there had been osteolysis in 3 of the patients anywhere from 6 months to 2 years post-surgery.No second surgeries were done because of it.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Type of Device: SMOOTH FIXATION PIN
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18892882
• MDR Text Key: 337513659
• Report Number: 1220246-2024-01441
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867032811
• UDI-Public: 00888867032811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Device Catalogue Number: AR-4152DS
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other