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
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Laceration(s) (1946); Insufficient Information (4580)
Date of Event	12/14/2022
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) 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.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event is not confirmed without the device being returned or any photos provided.The most likely cause of the reported failure can be attributed to user error due to misaligned insertion.

• Brand Name: DISP INSTRS KIT FOR MINI S-TAK
• Common Device Name: 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
• Report Number: 1220246-2023-06022
• Device Sequence Number: 6686811
• Product Code: MDM
• UDI-Device Identifier: 00888867010185
• UDI-Public: 00888867010185
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 Model Number: DISP INSTRS KIT FOR MINI S-TAK
• Device Catalogue Number: AR-1322DSC
• Device Lot Number: 14773374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown