MAUDE Adverse Event Report: ARTHREX, INC. PIN DRIVER ATTACHMENT 1.0-2.4 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	PIN DRIVER ATTACHMENT 1.0-2.4 MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a mica surgery the device did not grip the 2.4 k wires properly.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device from stryker.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed.The manufacturer evaluation revealed the clamping system in the drive shaft is worn out and the bearing is leaking.

• Brand Name: PIN DRIVER ATTACHMENT 1.0-2.4 MM
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 21919940
• Report Number: 1220246-2025-01781
• Device Sequence Number: 21088063
• Product Code: HWE
• UDI-Device Identifier: 00888867100176
• UDI-Public: (01)00888867100176(11)230201(10)15058215
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PIN DRIVER ATTACHMENT 1.0-2.4 MM
• Device Catalogue Number: AR-300PD24
• Device Lot Number: 15058215
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown