MAUDE Adverse Event Report: ARTHREX, INC. DISP KIT, CURVED, KNOTLESS HIP FIBERTAK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISP KIT, CURVED, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
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 10/4/2023, it was reported by a sales representative via phone that an ar-3636h self bunching kl 1.8 fibertak, hip, and an ar-3638dhc disposables kit for knotless hip fibertak suture anchor, curved had an issue.During a hip labral repair procedure on (b)(6) 2023, when the surgeon was trying to put the 4th anchor in, she drilled as per the required technique and felt resistance when inserting the anchor.When using a mallet to insert the anchor, a part of the metal insertion shaft broke off inside the patient's bone.The broken piece was able to be removed by 90%, but the distal end remained in the bone.Another larger anchor from a competitor was used to complete the procedure successfully with no harm to the patient.There was a case delay of 30 minutes, and no additional anesthesia was administered.After the procedure, it was noticed that the curved guide looked slightly bent, and the drill wasn't entering through the device as it normally did.Nothing had broken off the curved guide.Both devices were available for return.No pictures were taken.
Additional Manufacturer Narrative
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-applied excessive force and/or prying/leveraging the device during insertion.

• Brand Name: DISP KIT, CURVED, KNOTLESS HIP FIBERTAK
• 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: 18055661
• Report Number: 1220246-2023-08520
• Device Sequence Number: 5913961
• Product Code: LXH
• UDI-Device Identifier: 00888867295544
• UDI-Public: 00888867295544
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/15/2025

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: DISP KIT, CURVED, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3638DHC
• Device Lot Number: 15078448
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• 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