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

Model Number	DRIVER SHAFT, T4, SELF RETAINING,MINI AO
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2021
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.
Event or Problem Description
It was reported that during a (b)(6) 2021 small finger metacarpal orif procedure the tip of an ar18700-09, driver shaft (lot 1391937), broke off in the head of a screw in the patient.The tip of the driver was unable to be retrieved and remains in the screw head that is implanted in the patient.
Additional Manufacturer Narrative
It was reported that the driver had broken off into the screw head.The reported event is confirmed upon investigation of the returned product.- visual evaluation identified that the tip of the driver had fractured.Additionally, unrelated to the reported event, the tip was found to have twisted.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is over torquing the driver leading to the tip breakage.

• Brand Name: DRIVER SHAFT, T4, SELF RETAINING,MINI AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11230961
• Report Number: 1220246-2021-02501
• Device Sequence Number: 17169824
• Product Code: LXH
• UDI-Device Identifier: 00888867313781
• UDI-Public: 00888867313781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRIVER SHAFT, T4, SELF RETAINING,MINI AO
• Device Catalogue Number: AR-18700-09
• Device Lot Number: 1391937
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other