MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,50MM LGTH; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,4.0 STD,50MM LGTH
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/14/2021
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.
Event or Problem Description
It was reported that during a medial malleolus osteotomy and fixation procedure, the compression ft screw, ar-8740-50h, broke while being inserted into the hole drilled using a profile drill and long drill.The broken part was at the conjunction of the cortical and cancellous thread.The screw broke when only 1cm was inserted.The broken fragments were removed and the case was completed with an ar-8740-48h with no adverse effect to the patient.
Additional Manufacturer Narrative
Complaint was confirmed.Visual observations on the returned ar-8740-50h compression screw, showed that the screw had broken 0.34 inches from the head of the screw (right were the taper section ends).The returned ar-8740-50h was reviewed for critical dimensions at the head of the screw (major diameter) and minor diameter at the end of the screw.The device met all specifications as received.A most likely cause for this event includes improper bone preparation prior to insertion and bending/leveraging the screw while inserting into hard bone.

• Brand Name: COMPR FT SCRW,4.0 STD,50MM LGTH
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11301226
• Report Number: 1220246-2021-02556
• Device Sequence Number: 10983730
• Product Code: HRS
• UDI-Device Identifier: 00888867127937
• UDI-Public: 00888867127937
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: COMPR FT SCRW,4.0 STD,50MM LGTH
• Device Catalogue Number: AR-8740-50H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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