MAUDE Adverse Event Report: ARTHREX, INC.; PLATE, FIXATION, BONE

Lot Number UNK/PENDING PART NUMBER

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2021

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2021, it was reported by a sales representative via sems that an ar-8950sd-10 driver, became twisted.This was discovered taking out a screw and the driver twisted and became deformed.There was no additional information provided.Additional information 10/27/2021 on 10/27/2021, it was reported by a sales representative via email that an ar-8950sd-10 driver, became twisted when removing a 4.0 headless compression screw from the subtalar joint.The surgeon used a trephine to release screw from bone then pulled the screw out with a hemostat.The revision was being perform for painful hardware.

• Brand Name: UNK
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12814656
• MDR Text Key: 280805825
• Report Number: 1220246-2021-03926
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867198340
• UDI-Public: 00888867198340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNK/PENDING PART NUMBER
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/26/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other