MAUDE Adverse Event Report: ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	EASY-OUT, MINI/STANDARD COMPRESSION FT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a metal removal of two screws ar-8730-42hs (lot 10327710) and ar-8730-46hs (lot 10327712) the head of the screw ar-8730-46hs (lot 10327712) broke during unscrewing with the normal screwdriver for the device.The device ar-8737-62 (lot 1391931) was then used to grasp the broken screw and also broke.The broken screw had to be chiseled free to remove it, which caused much damage to the bone.The duration of the surgery was prolonged by approximately 45 minutes due to the failures.No broken parts remained inside the patient.The surgery was finished successfully and it was not necessary to do a second surgery.
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.
Additional Manufacturer Narrative
Complaint confirmed, approximately.08 in broke off at the distal end of the threaded tip.Relevant and available critical dimensions, and material were found to meet specifications.As described in the event description, a likely cause of the broken tip is using the device to attempt removing the screws.

• Brand Name: EASY-OUT, MINI/STANDARD COMPRESSION FT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13395975
• Report Number: 1220246-2022-04354
• Device Sequence Number: 20002533
• Product Code: LXH
• UDI-Device Identifier: 00888867263833
• UDI-Public: 00888867263833
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/09/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: EASY-OUT, MINI/STANDARD COMPRESSION FT
• Device Catalogue Number: AR-8737-62
• Device Lot Number: 1391931
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown