MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T8 HEXALOBE CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T8 HEXALOBE CANNULATED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery four drivers broke during removal of the screw.No harm for patient, operator or third party was reported.Update (b)(6) 2022: removal of plate and screws was performed.There was no harm for patient, operator or third-party.Another screw driver was used to finish the surgery successfully.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6) 2022: the part and lot numbers of broken drivers were received: ar-8610d-25, lot 6045184103 ar-8737-25, lot 01391809 ar-8610d-30, lot (10)1392150 ar-8737-26, lot (10)1392118.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection it was noted that the drive geometry at the distal tip returned ar-8610d-30 had twisted.No fragments were returned for inspection.It was not indicated if a torque indicating adapter had been used with the device.A probable cause is attributed to over-torquing/over-engaging the driver within the screw head.Also noticed that some part of the red paint is coming off.

• Brand Name: DRIVER SHAFT, T8 HEXALOBE CANNULATED
• 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: 15249447
• Report Number: 1220246-2022-05399
• Device Sequence Number: 5847207
• Product Code: LXH
• UDI-Device Identifier: 00888867197275
• UDI-Public: 00888867197275
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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, T8 HEXALOBE CANNULATED
• Device Catalogue Number: AR-8610D-30
• Device Lot Number: 1392150
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown