MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T4, NON-RETAINING, MINI AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T4, NON-RETAINING, MINI AO
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed.Two unpackaged ar-18700-03 drivers were received for investigation.Visual inspection under micro-vu id: (b)(4) identified that the distal tip of one of the two returned drivers had broken.No fragments were returned for inspection.A probable cause is attributed to over-torquing/over-engaging the driver within the screw head.Additionally, corrosion was present along both driver shafts.The cause remains undetermined.
Event or Problem Description
On 04/18/2022, it was reported by a distributor via sems that (2) ar-18700-03 driver shafts are rusted, and stripped.Also an ar-18700-29 driver shaft, half of the tip broke-off.This was discovered on (b)(6) 2022 during a ulna and radius orif.The case was completed using a mosquito clamp as there was no other driver available.There was no patient effect reported.

• Brand Name: DRIVER SHAFT, T4, NON-RETAINING, MINI AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14602203
• Report Number: 1220246-2022-05026
• Device Sequence Number: 5562670
• Product Code: LXH
• UDI-Device Identifier: 00888867303553
• UDI-Public: 00888867303553
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/06/2022

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, T4, NON-RETAINING, MINI AO
• Device Catalogue Number: AR-18700-29
• Device Lot Number: 1392042
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown