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	Foreign Body In Patient (2687)
Date of Event	11/24/2021
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 the initial plan of the surgery was an metal removal with the two screws according to minimally invasive chevron & akin osteotomy, but the distal screw simply broke off at approx.5mm.The remaining screw remained embedded in the bone.The proximal screw could be unscrewed well at first until 7-8 mm outside the bone.After that the surgeon was not able to move the screw a single mm.The screw head was screwed through and the surgeon wanted to go back to the initially planned metal removal.While implanting it the tip of the extractor broke off and blocked the screw, so that it was not possible to insert another attachment.In the end the surgeon had to cut the protruding part of the screw with a saw blade and leave the rest of the screw in the bone.It is currently unknown if the patient is harmed to the issue but the surgery time was extended from 5 minutes to 1 hour.07-dec-2021 update: part number and lot number of the broken screw provided.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13087946
• Report Number: 1220246-2021-04205
• Device Sequence Number: 5084521
• Product Code: HRS
• UDI-Device Identifier: 00888867303997
• UDI-Public: 00888867303997
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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 Expiration Date: 05/31/2024
• Device Model Number: COMPR FT SCRW,3.5 MINI, 42MM
• Device Catalogue Number: AR-8730-42HS
• Device Lot Number: 10327710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/27/2021
• Date Device Manufactured: 06/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown