MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, CANNULATED HEX, LONG, 3.5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER, CANNULATED HEX, LONG, 3.5MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2021
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 distal calc slide procedure the surgeon was using the ar-8946-08 driver to insert the screw.Upon insertion, the driver tip broke off in head of the screw.The driver tip was fully removed from the screw head, and the case was completed by using a back up driver.
Additional Manufacturer Narrative
Complaint confirmed, a piece of the drive feature broke off.The fragment was not returned.The feature could not be measured due tot he damage and deformation present.The device met material specifications.The cause of the even is undetermined, however likely cause include overtorquing the device, shallow driver engagement depth; prying/leveraging the device during use.

• Brand Name: DRIVER, CANNULATED HEX, LONG, 3.5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11761542
• Report Number: 1220246-2021-03005
• Device Sequence Number: 19837472
• Product Code: LXH
• UDI-Device Identifier: 00888867201781
• UDI-Public: 00888867201781
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 05/10/2021

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, CANNULATED HEX, LONG, 3.5MM
• Device Catalogue Number: AR-8946-08
• Device Lot Number: 021529
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1