MAUDE Adverse Event Report: ARTHREX, INC. SHARP HOOK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SHARP HOOK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2021
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 during a case the surgeon inserted the screw then the head of the driver snapped off in screw.The surgeon used the dental pick to get the driver shaft out of the headless screw and the pick broke.All was retrieved.The case was completed with no further issues.The patient is fine to date.The case was an orif of 3rd and 4th metacarpal.
Additional Manufacturer Narrative
Complaint confirmed, the tip is broken.According to the event description, the device was used outside of its intended use.

• Brand Name: SHARP HOOK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11761489
• Report Number: 1220246-2021-03001
• Device Sequence Number: 4015756
• Product Code: LXH
• UDI-Device Identifier: 00888867052314
• UDI-Public: 00888867052314
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/11/2021

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: SHARP HOOK
• Device Catalogue Number: AR-8943-21
• Device Lot Number: 6671930
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/11/2021
• Patient Sequence Number: 1