MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; SCREW, FIXATION, BONE

Model Number TENO SCRW,BIO-COMP

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/09/2022

Event Type  malfunction  

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) 2022, it was reported by a sales representative via phone that a ar-1530bc inserters tip broke.This occurred on (b)(6) 2022 during a hand and wrist procedure when inserting the screw the tip of the inserter broke off, and remained stuck in the screw.The screw sat fine, and was left in the patient with the broken fragment stuck in it.No additional information provided.

• Brand Name: TENO SCRW,BIO-COMP
• Type of Device: SCREW, 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: 14546924
• MDR Text Key: 300733248
• Report Number: 1220246-2022-04971
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867018600
• UDI-Public: 00888867018600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051726
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1530BC
• Device Lot Number: 11793699
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/09/2022
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1