MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,26MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO,26MM LGTH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 was 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 dipj fusion of the index finger, the surgeon was attempting to insert a 2.5 micro compression screw, (b)(4), one of the cutting flutes broke off of the distal end of the screw.The surgeon used a double ended k-wire and a profile drill for micro hcs and a 2.0 drill bit to a depth of 24mm to prepare the bone.The small cutting flute was lodged in the canal of the proximal phalanx of the index finger and could not be retrieved, however, the surgeon was not concerned of the piece floating around.Additional information obtained.The case was completed just as planned.The surgeon used a second 2.5 micro hcs and placed it over the broken hcs.

• Brand Name: COMPR FT SCRW,2.5 MICRO,26MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7691730
• Report Number: 1220246-2018-00550
• Device Sequence Number: 2771376
• Product Code: HWC
• UDI-Device Identifier: 00888867126916
• UDI-Public: 00888867126916
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132217
• 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): 07/16/2018

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,26MM LGTH
• Device Catalogue Number: AR-8725-26H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/16/2018
• 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
• Patient Age: 56 YR