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

Lot Number	UNK/PENDING PART NUMBER
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem 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
• Common Device Name: 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
• Report Number: 1220246-2021-03926
• Device Sequence Number: 4957478
• Product Code: HRS
• UDI-Device Identifier: 00888867198340
• UDI-Public: 00888867198340
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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 Lot Number: UNK/PENDING PART NUMBER
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown