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

Model Number	SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2021
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 an acl revision procedure, when the surgeon was removing the screw the tip of the ar-1896, broke.It is unknown at this time if the screw removed is an arthrex device.All pieces were removed.The case was competed using a competitor device.The ar-1896 will be returned.
Additional Manufacturer Narrative
Complaint confirmed, the drive feature broke off and was not returned.The feature could not be measured, but review of the certificate of conformance from the supplier confirms the material met specifications.The device is also damaged at the proximal and appears to have been impacted.A likely cause of the broken drive feature is user-applied mechanical forces.

• Brand Name: SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11802291
• Report Number: 1220246-2021-03069
• Device Sequence Number: 1099291
• Product Code: LXH
• UDI-Device Identifier: 00888867022423
• UDI-Public: 00888867022423
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
• Device Catalogue Number: AR-1896
• Device Lot Number: 8002044
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1