MAUDE Adverse Event Report: ARTHREX, INC. SCRWDRV,CANN.,PINLOCK II,3.5MM HEX; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that an ar-1896 scrwdrv,cann.,pinlock ii,3.5mm hex snapped during use.This occurred on (b)(6) 2024 in (b)(6) hospital during an acl revision.It was reported that a metal interference screw was being inserted into a femoral tunnel.The femoral tunnel diameter was 10mm, btb graft was 10mm and the surgeon selected a 9mm screw.On insertion the surgeon noted the "tough" insertion and with roughly 2 turns to go the screw inserter snapped at the hex driver point (pictured).The broken fragment was left in the insertion point of the screw.The nitiol wire was left in place, so that the fragment was not lost in the joint space and a grasper was used to remove the fragment.The case was completed successfully using an 8mm peek interference screw which had been tapped by the metal screw.There was case involvement.
Additional Manufacturer Narrative
Evaluation of the customer's attached picture of an ar-1896.Revealed that the hex tip of the device was broken off.The reported failure is most likely due to user error, specifically from applying excessive force while using the device.The complaint allegation is confirmed upon evaluation of the customer's attached picture.

• Brand Name: SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 19839481
• Report Number: 1220246-2024-06934
• Device Sequence Number: 6589185
• Product Code: LXH
• UDI-Device Identifier: 00888867022423
• UDI-Public: 00888867022423
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
• Device Catalogue Number: AR-1896
• Device Lot Number: 8002104
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown