MAUDE Adverse Event Report: ARTHREX, INC. T10 HEXALOBE SHAFT, SOLID, STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	T10 HEXALOBE SHAFT, SOLID, STRAIGHT
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/30/2022, it was reported by a distributor via sems that a ar-8950sd-10 t10 hexalobe shafts tip of the driver broke.This occurred during a case while putting a 2.7mm locking screw in the distal end of the plate, the tip of the screw driver broke within the screw.They noticed and tried to removed without success.No additional information provided.
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.One unpackaged ar-8950sd-10, t10 hexalobe shaft, solid, straight serial/batch number (b)(6) were received for investigation.Visual evaluation found that the devices hex tip was broken off.The fragments generated during the event were not returned for analysis.More in-depth visual evaluation found that the remaining hex tip was twisted.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: T10 HEXALOBE SHAFT, SOLID, STRAIGHT
• 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: 16173478
• Report Number: 1220246-2023-06127
• Device Sequence Number: 4341322
• Product Code: LXH
• UDI-Device Identifier: 00888867220010
• UDI-Public: 00888867220010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: T10 HEXALOBE SHAFT, SOLID, STRAIGHT
• Device Catalogue Number: AR-8950SD-10
• Device Lot Number: 1392145
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown