MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,32MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO,32MM LGTH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2021
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 tip of the screw broke during implant for a bunion case; the tip was retrieved from the patient.Another screw was used to complete the case.Patient is female, (b)(6) years old.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8725-32h screw (no batch identifier provided) was received for investigation.Breakage was noted to the distal threads of the screw, and it was identified using digital caliper id: 011 that approximately 31.46mm of the screw remained.Due to the returned condition of the device, the dimensions at the distal end where the breakage occurred could not be assessed.The fragments generated during this event were not returned for inspection.The observed damage is most likely the result of prying/leveraging forces applied to the screw during insertion.

• Brand Name: COMPR FT SCRW,2.5 MICRO,32MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12076120
• Report Number: 1220246-2021-03333
• Device Sequence Number: 19783543
• Product Code: HWC
• UDI-Device Identifier: 00888867303256
• UDI-Public: 00888867303256
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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 Model Number: COMPR FT SCRW,2.5 MICRO,32MM LGTH
• Device Catalogue Number: AR-8725-32H
• Device Lot Number: 10353732
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1