MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,34MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO,34MM LGTH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
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 during a interphalangeal joint fusion procedure upon inserting the 2.5.X 34mm headless compression screw the ar-8737-37, 1.5 mm hex cannulated driver shaft snapped off in the head of the screw.The broken driver tip was removed by using pliers.The surgeon decided to leave the screw in the distal aspect of the 1st metatarsal because it was not in the joint.There were not any unplanned incisions made other than the incision to use a larger screw 3.5 headless compression screw to complete the joint fusion.Ee source data attached.Additional information obtained 06/10/2020: the arthrex 2.5 x 34mm headless compression screw (ar-8725-34h) was implanted into the distal aspect of the 1st metatarsal head.The screw was supposed to go from the distal aspect of the 1st metatarsal head, advancing to fuse the interphalangeal joint together.The screw was not protruding into the joint so the surgeon made the decision to leave it in the distal aspect of the 1st metatarsal head.Surgeon then made a separate incision to insert a 3.5 x 36mm headless compression screw in order to complete the ipj fusion, which was successful.The ar-8737-37, hex driver is being returned for evaluation.

• Brand Name: COMPR FT SCRW,2.5 MICRO,34MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10212049
• Report Number: 1220246-2020-01926
• Device Sequence Number: 19359785
• Product Code: HWC
• UDI-Device Identifier: 00888867303263
• UDI-Public: 00888867303263
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• 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 Model Number: COMPR FT SCRW,2.5 MICRO,34MM LGTH
• Device Catalogue Number: AR-8725-34H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• 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