MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 20MM VAL SCREW, TI; PLATE, FIXATION, BONE

Model Number 2.4 X 20MM VAL SCREW, TI

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 11/21/2019

Event Type  Injury  

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 Description

It was reported by the sales rep, that during a distal radius fracture repair, the surgeon implanted an ar-8919vsl-03, volar distal radius plate and 3 screws, as the surgeon was placing the last two locking screws ar-8724v-20, the screws went completely through the volar plate.The surgeon then removed all five screws and plate, causing a 30 minute delay in surgery.Additional anesthesia needed to be administered to the patient for the delay.The surgeon completed the case using a different ar-8724vsl-20, volar plate and five new ar-8724v-20, screws without further delays or complications.Additional information obtained 11/25/19: the sales rep has reviewed the original event description and has provided an updated description with corrected part numbers: it was reported by the sales rep, that during a distal radius fracture repair, the surgeon implanted an ar-8916vsl-03 (lot 10307271), volar distal radius plate.The surgeon placed all five of the screws into the place but noticed that the two distal screws, ar-8724v-20, had passed all the way through the locking holes onto the patients radius bone.They had attempted to engage the screw with the driver and reverse them through the plate but were unable to get them to pass back through.At this point they needed to remove the entire plate and replace it with another ar-8916vsl-03 and redo the fixation.This process took an additional 30 minutes.The surgeon noted that the fixation was not adversely affected by this process and the anesthesiologist advised the sales rep that the patient had no ill effects from the additional time under anesthesia other than just a longer procedure.The first ar-8916vsl-03 lot 10307271 (qty 1) and the screws implanted with that plate, at-8724v-20 (qty 5) were all removed during the same procedure and replaced with new.

Manufacturer Narrative

Complaint not confirmed, some damage was observed that most likely occurred during insertion and/or removal, but the screws were found to meet dimensional specifications.

• Brand Name: 2.4 X 20MM VAL SCREW, TI
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9446136
• MDR Text Key: 170693074
• Report Number: 1220246-2019-01473
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867045620
• UDI-Public: 00888867045620
• Combination Product (y/n): N
• PMA/PMN Number: K131474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2.4 X 20MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-20
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other