MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DISPOSABLES CURVED KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number FIBERTAK DISPOSABLES CURVED KIT

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, it was reported by a sales representative via phone that a ar-3638dc fibertak tip broke off in a patient during an unknown procedure.This was discovered 2 weeks post op when an x-ray was taken at the facility and a fragment was discovered.No additional information provided.Additional information requested.

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.

• Brand Name: FIBERTAK DISPOSABLES CURVED KIT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14337585
• MDR Text Key: 295049586
• Report Number: 1220246-2022-04893
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867287433
• UDI-Public: 00888867287433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAK DISPOSABLES CURVED KIT
• Device Catalogue Number: AR-3638DC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1