MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,30MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO,30MM LGTH
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/26/2018
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 is expected but has not returned for evaluation.The 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 hand procedure, the tip of the driver, ar-8737-37 broke off into the ar-8725-30h upon implantation.Despite varying attempts, the tip of the driver could not be removed and the portion of the screw that was remaining outside of distal phalanx was cut off with wire cutter.A second surgery is not necessary in this case.Additional information obtained: the case was an ip fusion.The case was completed with the surgeon cutting off the remaining distal end of the screw that was still outside of the phalanx.X-rays were taken, however, rep does not have copies of these.She will reach out to the surgery center to see if she can get a copy.

• Brand Name: COMPR FT SCRW,2.5 MICRO,30MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7693336
• Report Number: 1220246-2018-00554
• Device Sequence Number: 1121147
• Product Code: HWC
• UDI-Device Identifier: 00888867126930
• UDI-Public: 00888867126930
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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: No Information
• Device Model Number: COMPR FT SCRW,2.5 MICRO,30MM LGTH
• Device Catalogue Number: AR-8725-30H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-8737-30H, HEX DRIVER
• Outcome Attributed to Adverse Event: Other