MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DISPOSABLES STRAIGHT KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FIBERTAK DISPOSABLES STRAIGHT KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2023
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
It was reported that during a shoulder stabilization surgery using a 1.8 knotless fibertak the drill broke off inside the patient.The customer reported that the surgeon was unable to retrieve the fragment.However the surgeon was confident that the drill tip was in the bone.The surgery was finished successfully with a new device with a different part number.It was not necessary to switch the surgical technique or do a second surgery.
Event or Problem Description
Update dw 09-nov-2023 the customer was not able to determine which anchor broke during the surgery however the following devices were used 5x ar-3638, 2x ar-4068-25tr and 2x ar-2923bc-1.Update dw 10-jan-2024: a review of the provided pictures has been performed and as the customer initially reported that a fibertk anchor broke the only reasonable device remained the ar-3638 with the lot number 15082448.
Additional Manufacturer Narrative
Additional information.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 of the reported failure can be attributed to user error misalignment the insertion.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: FIBERTAK DISPOSABLES STRAIGHT KIT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 18054562
• Report Number: 1220246-2023-08516
• Device Sequence Number: 6074619
• Product Code: LXH
• UDI-Device Identifier: 00888867287440
• UDI-Public: 00888867287440
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: FIBERTAK DISPOSABLES STRAIGHT KIT
• Device Catalogue Number: AR-3638DS
• Device Lot Number: 15082448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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