MAUDE Adverse Event Report: ARTHREX, INC. CURVED SPEAR, FIBERTAK, REUSABLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CURVED SPEAR, FIBERTAK, REUSABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
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 during a labrum fix with fiber tak 1.8mm surgery the anchor could not be inserted from the drill sleeve and did break off.The piece did not break off inside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device and pushlock refix surgical technique.It was not necessary to do a second surgery.
Event or Problem Description
Update dw 20-feb-2025: further information was provided that an ar-3636 anchor was used with the device.Update dw 25-feb-2025: further information was provided that nothing of the spear has broken off.Only the handle part of the anchor broke inside the spear.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed per update dw 25-feb-2025.Upon visual inspection, it was noted that the device had an anchor at the end of the shaft of the sleeve, sutures were stuck in the handle, and the proximal end of the handle portion of the mating part ar-3636 returned.Functional testing was not performed due to the damage to the device.Per surgical technique knotless 1.8 fibertak® soft anchor for glenoid labrum repair note 2 - note: if insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.Avoid excessive impaction as this could lead to inserter damage and/or breakage.Warning: to help avoid inserter breakage and potential patient injury: avoid excessive impaction 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.¦ visually inspect the inserter for potential breakage after each implantation.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: CURVED SPEAR, FIBERTAK, REUSABLE
• 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: jared engle ; 8009337001
• MDR Report Key: 21039678
• Report Number: 1220246-2024-09130
• Device Sequence Number: 18050211
• Product Code: LXH
• UDI-Device Identifier: 00888867354265
• UDI-Public: (01)00888867354265(11)230501(10)0072313
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 03/19/2025

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: CURVED SPEAR, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610CTC
• Device Lot Number: 0072313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: Not provided; 03/04/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/27/2025; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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