MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI, 36MM; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,3.5 MINI, 36MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial arthrodesis surgery for hallux rigidus on 22nd (b)(6)2022 the patient developed an granuloma formation.A surgical exploration was performed and a fragment of the screw was identified.An additional surgery was performed on (b)(6) 2023 to perform a fresection of the ganuloma.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint was confirmed.One unpackaged ar-8730-36hs batch 14695453 was received for evaluation.Visual inspection found that a small, tiny piece of the mini compression screw was received.Due to the device's size, it is impossible to perform measurements.However, the received piece color matches the finish: anodize teal color per drawing c16497 at revision 2.The most likely cause(s) for the reported failure can be a user error, improper bone preparation, or misaligned insertion.

• Brand Name: COMPR FT SCRW,3.5 MINI, 36MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 16914538
• Report Number: 1220246-2023-06724
• Device Sequence Number: 6423348
• Product Code: HRS
• UDI-Device Identifier: 00888867303966
• UDI-Public: 00888867303966
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K201132
• 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,Followup
• Report Date (Section B): 10/18/2024

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, 36MM
• Device Catalogue Number: AR-8730-36HS
• Device Lot Number: 14695453
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown