MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T-15, LONG
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the tip of both devices were found to be twisted.The tip of one device was also broken and missing approximately 1mm.It is stated in the complaint that torque indicating device was not used.It is recommended to use a torque indicating device to prevent over-torquing and damaging the device.A likely cause of the event is over-torquing the driver.
Event or Problem Description
On (b)(6)2021 it was reported by a sales representative via sems that two ar-9545-t15-03 driver shafts and one ar-9545-t15-02 have tips that are twisted and bent.In addition, the plastic tips of the ar-9165-cdg are broken.There were no fragments broken off or any patient affect.All items were replaced and the case was completed successfully.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: DRIVER SHAFT, T-15, LONG
• 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: 13569415
• Report Number: 1220246-2022-04478
• Device Sequence Number: 6032973
• Product Code: LXH
• UDI-Device Identifier: 00888867225176
• UDI-Public: 00888867225176
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/21/2022

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, T-15, LONG
• Device Catalogue Number: AR-9545-T15-03
• Device Lot Number: 8001940
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown