MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK WITH SUTURETAPE; POWERED SURG ORTHOPEDIC INSTR

Model Number	FIBERTAK WITH SUTURETAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that after a surgery, the post-operative x-ray showed a drill tip still remaining in the patient, which wasn¿t realised during the operation.An additional surgery has been planned to remove the broken drill tip on (b)(6) 2025.Per complaint reporter there was no harm for patient, operator or third party.Update (b)(6) 20-aug: further information was received that the originally alleged device is incorrect.The alleged device is ar-3602.Description remains the same: tip broke during a latarjet procedure and that was discovered post-operatively with x-ray.Revision surgery has been performed on (b)(6).
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer provided photos noted the tip of a fibertak inserter had broken off.Refer to attachments.Based on the information provided which may include pictures, the 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 misuse due to applying excessive mechanical forces upon insertion, improper bone prep and/or prying/leveraging the device during use.The dfu for this device, dfu-0054-eo revision 6, warns the following: 7.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.8.Visually inspect all devices immediately after use for the potential of loose body remnants left behind in the patient.

• Brand Name: FIBERTAK WITH SUTURETAPE
• Common Device Name: POWERED SURG ORTHOPEDIC 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: jared engle ; 8009337001
• MDR Report Key: 22924139
• Report Number: 1220246-2025-03683
• Device Sequence Number: 13040677
• Product Code: HWE
• UDI-Device Identifier: 00888867206946
• UDI-Public: (01)00888867206946(11)241216(17)291130(10)15362425
• 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): 09/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FIBERTAK WITH SUTURETAPE
• Device Catalogue Number: AR-3602
• Device Lot Number: 15362425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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