MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI,32MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI,32MM LGTH
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/29/2019
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 requested/is expected but has 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 1st mtp joint fusion, the surgeon performed per the usual technique.The bone was prepped by drilling with k-wire and over-drill.The k-wire and drill were part of the required set.While inserting the compression screw, the screw shaft snapped leaving 2/3 of the screw in the bone.The head portion of the screw was removed from the patient and the case was completed by inserting a second screw in a different direction.The surgeon was able to achieve joint compression prior to plating.
Additional Manufacturer Narrative
Complaint confirmed, the device was received broken in two fragments.The device was found to meet specifications.The fracture is torsional, the most likely cause is continually applying torque when the device is not advancing or misaligned and/or prying and leveraging the device during insertion.

• Brand Name: COMPR FT SCRW,3.5 MINI,32MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8349714
• Report Number: 1220246-2019-00910
• Device Sequence Number: 19367426
• Product Code: HWC
• UDI-Device Identifier: 00888867127050
• UDI-Public: 00888867127050
• Combination Product (Y/N): N
• PMA/510(K) Number: K182361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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,32MM LGTH
• Device Catalogue Number: AR-8730-32H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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