MAUDE Adverse Event Report: ARTHREX, INC. VA LOCKING SCREW, 1.4X9MM; PLATE, FIXATION, BONE

Model Number	VA LOCKING SCREW, 1.4X9MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/21/2020
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 during an orif right ring finger and small metacarpals procedure one ar-18714v-09 locking screw broke during insertion into the plate.Upon final seating the head of the screw broke off during insertion.The threads of the broken screw are reported to remain in the patient under the plate.Also during the procedure two t4 drivers (one retaining an done non retaining) were compromised and not able to complete the full clockwise rotations necessary for flush seating of the locking screw heads.The drivers were the following: ar-18700-29 (lot 1391940) and ar-18700-09 (lot 1391937).The surgeon used jeweler's handles (all black and all silver) with the drivers.All screws were pre-drilled on power with a 1.1mm drill and implanted via manual insertion only, using the two fingers tight method.

• Brand Name: VA LOCKING SCREW, 1.4X9MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10484081
• Report Number: 1220246-2020-02137
• Device Sequence Number: 19143880
• Product Code: HRS
• UDI-Device Identifier: 00888867303713
• UDI-Public: 00888867303713
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• 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): 09/02/2020

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: VA LOCKING SCREW, 1.4X9MM
• Device Catalogue Number: AR-18714V-09
• Device Lot Number: 1063915
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/02/2020
• 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