MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI, 60MM; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI, 60MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2021
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 a metacarpal fracture, both 3.5 and 2.5 headless screws broke while being implanted.When screw was implanted and going past the isthmus of the metacarpal the headless screw broke.The surgeon attempted to remove the screw using the driver and broke the 1.5 hex driver.Then had to use the synthes screw removal which didn¿t work as well and resorted to having to burr down the screw flush to the metacarpal.Additional information provided 7/7/21: the lot number of the screw's were not located as the devices were discarded during the case.

• Brand Name: COMPR FT SCRW,3.5 MINI, 60MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12231478
• Report Number: 1220246-2021-03429
• Device Sequence Number: 20081477
• Product Code: HRS
• UDI-Device Identifier: 00888867303508
• UDI-Public: 00888867303508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• 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
• Report Date (Section B): 07/27/2021

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: COMPR FT SCRW,3.5 MINI, 60MM
• Device Catalogue Number: AR-8730-60H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1