MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,20MM LGTH, STRL; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO,20MM LGTH, STRL
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/08/2020
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 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 a micro compression screw, ar-8725-20hs, was being used in a procedure on the patient's middle finger.When the screw was placed, the tip of the screw broke within the bone hole and a fracture of the middle phalanx occurred around the damaged part.Although it was not confirmed whether the arthrodesis worked properly, the surgeon decided that it was difficult to remove the screw, and completed the operation with the screw left in the bone together with the broken pieces.

• Brand Name: COMPR FT SCRW,2.5 MICRO,20MM LGTH, STRL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10212079
• Report Number: 1220246-2020-01927
• Device Sequence Number: 16961717
• Product Code: HRS
• UDI-Device Identifier: 00888867278523
• UDI-Public: 00888867278523
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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 Expiration Date: 10/31/2024
• Device Model Number: COMPR FT SCRW,2.5 MICRO,20MM LGTH, STRL
• Device Catalogue Number: AR-8725-20HS
• Device Lot Number: 10433580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/30/2020
• 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