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	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-3636h fibertak inserter broke while inserting.Significant portion broke off, >3cm.Portion had to be drilled out.Surgeon could not remove the tip of the inserter and was left in the bone.This was discovered during use in a case, delay 10 minutes.Case completed using additional anchors.Ar-3638dhc is the suspected cause of the break.The guide did not appropriately line up the anchor to the hole.
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.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Visual inspection revealed that the returned part did not have any visual issues.Functional testing was performed and did not find an issue with the shaft inserter.The most likely cause of the reported failure can be attributed to misaligned insertion, prying, or leveraging the device during insertion with the matting part.

• 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: 18436834
• Report Number: 1220246-2024-00038
• Device Sequence Number: 15399011
• Product Code: LXH
• UDI-Device Identifier: 00888867295544
• UDI-Public: 00888867295544
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/22/2024

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: 12/06/2023
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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