MAUDE Adverse Event Report: ARTHREX, INC. DISP INSTRS KIT FOR MINI S-TAK; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number DISP INSTRS KIT FOR MINI S-TAK

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problem Laceration(s) (1946)

Event Date 12/14/2022

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) 2022, it was reported by a sales representative via sems that a ar-1322dsc disposable instruments kits 2.0mm drill, when drilling into the bone the drill cold welded into the guide.This occurred during a ucl repair on (b)(6) 2022, they attempted to remove the guide from the drill with a blade and biter.A second site was drilled but the anchor pulled out.The 2.4 mini biocomposite suturetak was being used.Opened disposable kit, used the 2.0mm drill, when drilling into the bone the drill cold welded into the guide.They attempted to remove the guide from the drill with a blade and biter.A second site was drilled but the anchor pulled out.The surgery was completed by using the two tunnels drilled as a bone bridge to tie over.

• Brand Name: DISP INSTRS KIT FOR MINI S-TAK
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 16086996
• MDR Text Key: 306534078
• Report Number: 1220246-2023-06022
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867010185
• UDI-Public: 00888867010185
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DISP INSTRS KIT FOR MINI S-TAK
• Device Catalogue Number: AR-1322DSC
• Device Lot Number: 14773374
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/14/2022
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other