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 Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/4/2025, a sales representative reported via phone that an ar-1787pj-cp internalbrace implant system had an issue during use in an internal brace procedure on (b)(6) 2025.When the surgeon was using the device, the threaded top portion of the cannulated 2.7 mm drill in that kit broke inside the patient¿s bone; it shattered into several fragments.The surgeon was able to remove a few of the fragments, but some remained inside the patient's bone.The surgeon opened another ar-1787pj-cp internalbrace implant system with lot number 15427045 to complete the procedure successfully with no further patient harm.The surgeon stated that no additional procedure was deemed necessary.Pictures and an x-ray were taken.There was a case delay of over 60 minutes, and additional anesthesia was administered to the patient.Additional information was requested.On 8/5/2025, the sales representative stated via phone that the patient did not experience any adverse events due to the additional anesthesia or the drill fragments being left inside the joint.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the photos provided, which show the broken fragments of the ar-1787pj-cp internalbrace¿ implant system, ligament augmentation repair, mini, peek, with jumpstart® dressing.Please reference photos attached.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 prying/leveraging the device during use.

• 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: jared engle ; 8009337001
• MDR Report Key: 22849196
• Report Number: 1220246-2025-03542
• Device Sequence Number: 20946875
• Product Code: MAI
• UDI-Device Identifier: 00888867295629
• UDI-Public: (01)00888867295629(11)250429(17)300228(10)15427818
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/17/2025

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: 15427818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown