MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T10, NON-RETAINING; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T10, NON-RETAINING
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
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
On 06/27/2024, it was reported by a sales representative via (b)(4) that an ar-18800-25 driver shaft and ar-8700rh ratcheting handle has been cold welded together.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
The complaint allegation has not been confirmed as the reported failure could not be replicated.One unpacked ar-18800-25 serial/batch number (b)(6) was received for investigation.The device was delivered for evaluation, independent of the ar-8700rh ratcheting handle.Visual inspection found that the hex tip of the driver was twisted.It was noted that the laser marks are fading most likely because the reprocessing of the device.Functional testing of batch 1392239 for the ar-18800-25 indicated that the driver does not become jammed within the ratcheting mechanism.No problem found.

• Brand Name: DRIVER SHAFT, T10, NON-RETAINING
• Common Device Name: ORTHOPEDIC MANUAL SURG 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: 19763678
• Report Number: 1220246-2024-06797
• Device Sequence Number: 18269370
• Product Code: LXH
• UDI-Device Identifier: 00888867385603
• UDI-Public: 00888867385603
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: DRIVER SHAFT, T10, NON-RETAINING
• Device Catalogue Number: AR-18800-25
• Device Lot Number: 1392239
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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