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

Model Number	COMPR FT SCRW,3.5 MINI, 42MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2020
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 that during a (b)(6) 2020 tmt fusion/lapidus procedure the surgeon was implanting a ar-8730-42h, compression ft screw, and after approximately 30mm was inserted the screw broke.The 12mm piece was retrieved but the 30mm that was inserted was left in.The screw was crossing the fusion site.Sales representative states surgeon would have liked more compression from the screw be did not think taking it out was the best option.Surgeon plated over the site to stabilize.No additional or larger incision were needed.The original plan was to use a headless screw across the fusion site for compression and a plat to stabilize.The technique remained the same but with not as much compression as was originally planned.Retrieved piece was discarded by the scrub tech.

• Brand Name: COMPR FT SCRW,3.5 MINI, 42MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11146664
• Report Number: 1220246-2021-02459
• Device Sequence Number: 676664
• Product Code: HRS
• UDI-Device Identifier: 00888867303331
• UDI-Public: 00888867303331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/11/2021
• 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