MAUDE Adverse Event Report: ARTHREX, INC. INTBRACE LGMNT REPR AUGMNT KIT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number INTBRACE LGMNT REPR AUGMNT KIT

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/26/2021

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 10/29/2021, it was reported by a arthrex employee via e-mail that while the surgeon was using an ar-1678-cp implant system, and inserted the screw into the bone hole created in the fibula, it was found that the tip of the screwdriver was broken and the broken piece fell off and remained in the patient's body.The surgeon tried to remove the broken piece, but it could not be removed, and the piece still remains in the patient's body.This was discovered during use in a lateral ligament of the foot on (b)(6) 2021.The case was completed by using a new ar-1678-cp.

• Brand Name: INTBRACE LGMNT REPR AUGMNT KIT
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 12814675
• MDR Text Key: 283596022
• Report Number: 1220246-2021-03927
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867020887
• UDI-Public: 00888867020887
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: INTBRACE LGMNT REPR AUGMNT KIT
• Device Catalogue Number: AR-1678-CP
• Device Lot Number: 11982155
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Date Device Manufactured: 10/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1