MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T25 HEXALOBE, CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T25 HEXALOBE, CANNULATED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a foot fixation surgery the tip of the device got twisted and broke off.There was no harm for patient, operator or third party reported.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8610d-65 was received for investigation.Visual inspection identified that the drive geometry at the distal tip of the returned ar-8610d-65 had broken.Due to the extent of the breakage present, accurate dimensions of the drive geometry were unable to be assessed.The fragment of the distal tip was not returned.A probable cause is attributed to over-torquing/over-engaging the driver during use.

• Brand Name: DRIVER SHAFT, T25 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: 13397411
• Report Number: 1220246-2022-04368
• Device Sequence Number: 14892065
• Product Code: LXH
• UDI-Device Identifier: 00888867197299
• UDI-Public: 00888867197299
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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
• Device Model Number: DRIVER SHAFT, T25 HEXALOBE, CANNULATED
• Device Catalogue Number: AR-8610D-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown