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

Model Number	EASY-OUT, MICRO COMPRESSION FT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2021
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 the inserter tip broke off during the anchor implant.The site had been pre-drilled.The tip was retrieved.They tried to use the ar-8737-61 to remove the anchor, but the metal in the device started to splinter.The anchor was removed with pliers.And the anchor was removed with pliers.Another anchor was used to complete the bunion case.Patient is female, (b)(6) years with hard bone.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8737-61, batch 1391932 was received for investigation.Visual inspection identified thread breakage at the distal tip of the device.The fragment generated during the event was not returned for analysis.Due to the returned condition of the device, the geometry at the distal tip could not be accurately assessed.The cause remains undetermined, although a probable cause can be attributed to user applied mechanical forces during use, such as through prying/leveraging.

• Brand Name: EASY-OUT, MICRO COMPRESSION FT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11841670
• Report Number: 1220246-2021-03098
• Device Sequence Number: 4490924
• Product Code: LXH
• UDI-Device Identifier: 00888867263802
• UDI-Public: 00888867263802
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/01/2021

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: EASY-OUT, MICRO COMPRESSION FT
• Device Catalogue Number: AR-8737-61
• Device Lot Number: 1391932
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1