MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI, 50MM; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI, 50MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
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 device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a 3.5 mini compression screw, ar-8760-50h, was being used in a medicarpal fracture repair.The surgeon began by drilling with a 2.7 drill and then inserting the screw with a ratcheting handle instead of on power.During advancement, the surgeon felt something slip and pulled the ratcheting handle and guidewire out of the joint and took an x-ray.With the x-ray, he saw that the screw had broken at about 1/4 of the way down, leaving 3/4 of the screw in the tunnel.The head of the screw was able to be backed out and the was able to acquire proper fixation with the portion that was left in the bone.The case was then completed without further incident.

• Brand Name: COMPR FT SCRW,3.5 MINI, 50MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9081127
• Report Number: 1220246-2019-01319
• Device Sequence Number: 14349363
• Product Code: HWC
• UDI-Device Identifier: 00888867303379
• UDI-Public: 00888867303379
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: COMPR FT SCRW,3.5 MINI, 50MM
• Device Catalogue Number: AR-8730-50H
• Device Lot Number: 10282453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 91