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	No Code Available (3191)
Date of Event	02/06/2020
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 during a chevron osteotomy procedure as the surgeon put in the first 3.5 x 42 mm mini screw, the screw broke completely in half.The latter half of the screw came out with the driver but the surgeon had to make a bigger incision from their previous mis incision to then use a ronjour to get out the first half of screw that was still in the bone.The surgeon then used a new guide wire and used a 40mm screw to fix the correction.Then the surgeon went to use another 42mm screw as a second point of fixation and this screw was stripped and broke off approx 1/4 of the length.However, that screw was holding up well across the osteotomy and gave the bone a good hold so the surgeon chose to keep it in since it was holding well.In conclusion, the first screw used (3.5 x 42) completely broke in half.The second screw (3.5 x 40) went in fine.The third screw (3.5 x 42) had the end break off, approx 1/4 of it, but held up in the bone and stayed in.Request sent to rep for part and lot numbers of complaint devices.Additional information received on 02/12/2020: the rep provided the part and lot numbers of the two broken screws (ar-8730-42h / lot: 10448214 & lot: 10504055).

• 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: 9751229
• Report Number: 1220246-2020-01718
• Device Sequence Number: 11487052
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: 10448214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other