MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI, 42MM; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI, 42MM
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	10/22/2019
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by the sales rep, that during an ipj fusion procedure, the surgeon prepped the insertion socket using the profile drill, upon insertion of the ar-8730-42h, compression screw the screw snapped approximately 1/3 the length of the screw.The surgeon removed all pieces causing a delay in case of 1 1/2 hours.The case was completed using a different ar-8730-42h, compression screw.Additional information 10/24/2019: the sales rep has stated that the anesthesiologist had to use additional anesthesia due the delay in case.Where the screw snapped it was flush with the skin and the surgeon was forced to cut a wider and deeper incision in order to access the screw half to remove it from the patient's toe.The surgeon ended up using a larger diameter screw (4.0 mm headless ft screw, ar-8740-42h) to complete the procedure.Surgeon did not want to use the same size screw again in case it would snap in half again.The patient is a small female with petite bone structure.
Additional Manufacturer Narrative
Complaint was confirmed.Visual observations on the returned ar-8730-42h, revealed a fracture 1/4 of an inch right after the taper threaded section of the screw.The returned ar-8730-42h was reviewed for critical dimensions at the head of the screw (major diameter) and minor diameter at the end of the screw.The device met all specifications as received.A most likely cause for this event includes improper bone preparation prior to insertion and bending/leveraging the screw while inserting into hard bone.

• Brand Name: COMPR FT SCRW,3.5 MINI, 42MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9324361
• Report Number: 1220246-2019-01412
• Device Sequence Number: 2271945
• Product Code: HWC
• UDI-Device Identifier: 00888867303331
• UDI-Public: 00888867303331
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 01/27/2020

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, 42MM
• Device Catalogue Number: AR-8730-42H
• Device Lot Number: 10322903
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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