MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART; BIO SOFT TISSUE FIXATN FASTENR

Model Number	IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
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 12/21/2023, it was reported by a sales representative via phone that an ar-1787pj-cp internalbrace implant system, ligament augmentation repair, had an issue with the 2.7mm drill.When drilling in the bone, the drill bit shattered and left shards in the bone.The surgeon removed the fragments of the drill bit and performed an x-ray when the patient was open to confirm that all the fragments were removed.The case was completed by doing a primary ligament repair using an ar-899ost fibertak dx suture anchor, and the internal brace was not incorporated into the procedure.There was a 15-20 minute delay in the case with no additional anesthesia administered.This was discovered during an atfl reconstruction procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion, prying/leveraging, and/or excessive force used during insertion.

• Brand Name: IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART
• Common Device Name: BIO SOFT TISSUE FIXATN FASTENR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18510765
• Report Number: 1220246-2024-00345
• Device Sequence Number: 6991649
• Product Code: MAI
• UDI-Device Identifier: 00888867295629
• UDI-Public: 00888867295629
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART
• Device Catalogue Number: AR-1787PJ-CP
• Device Lot Number: 14990010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown