MAUDE Adverse Event Report: ARTHREX, INC. DRV SFT,T10 HEXALOBE,CANN,STR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRV SFT,T10 HEXALOBE,CANN,STR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2021
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 the surgeon was attempting to implant ar-8740-38h standard headless screw.After the surgeon drilled and profile drilled over a k-wire, the screw would not get flush.X-ray was taken to verify that it was not too long and it was confirmed that is was not.The surgeon went back to the screw and tried to screw it in more, and the ar-8737-38 driver tip snapped off in the screw.The surgeon was able to remove the broken piece and used another driver ar-8737-26 to try to complete the surgery and it also snapped off at the end of the driver tip.The surgeon was able to remove the broken piece from the screw.Another screw driver set was opened and the surgeon used a non-cannulated driver tip to advance the screw so that it was flush with the bone.

• Brand Name: DRV SFT,T10 HEXALOBE,CANN,STR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11724894
• Report Number: 1220246-2021-02949
• Device Sequence Number: 16914312
• Product Code: LXH
• UDI-Device Identifier: 00888867046214
• UDI-Public: 00888867046214
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/26/2021

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: DRV SFT,T10 HEXALOBE,CANN,STR
• Device Catalogue Number: AR-8737-26
• Device Lot Number: 1391916
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1