MAUDE Adverse Event Report: ARTHREX, INC. SELF BUNCHING KL 1.8 FIBERTAK, HIP; NON-DEGRADABLE FIXATN FASTENER

Model Number	SELF BUNCHING KL 1.8 FIBERTAK, HIP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a labral repair hip surgery two anchors broke off inside the patient.The surgeon burred away the acetabulum in order to get the broken piece.The broken piece was retrieved from patient.Further it was reported that the surgeon abandoned the repair.There was no harm for patient, operator or third party.It was not necessary to do a second surgery.Update swit: on (b)(6) 2024: a kl hip surgery with fibertak driver shaft surgery was performed.With two anchors part of the shaft broke off in the patient's bone and had to be fished out.Correct technique was used.It took one and half hours for the surgeon attempted to fish the broken pieces (one of the shafts broke into 3 separate bits) out of the patient's acetabulum with great difficulty.Update swit: on (b)(6) 2024: the other three anchors pulled out.He decided to carry out with the repair and just burred the femoral head.The surgeon did not want to repair the labrum anymore so abandoned that part of the surgery.The surgeon said that him burring the head away still helped with impingement.The one anchor was left inside the patient.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint is confirmed.The complaint is confirmed based on the customer provided photo, which displays that one of the tips of the distal end of the inserter shaft was bent.No picture was provided of the implant.However, without the return of the device for physical evaluation.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion, excessive force used during suture passing/tightening /tensioning.No change in harm was identified.

• Brand Name: SELF BUNCHING KL 1.8 FIBERTAK, HIP
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 18766084
• Report Number: 1220246-2024-01080
• Device Sequence Number: 4525604
• Product Code: MBI
• UDI-Device Identifier: 00888867362864
• UDI-Public: 00888867362864
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SELF BUNCHING KL 1.8 FIBERTAK, HIP
• Device Catalogue Number: AR-3636H-1
• Device Lot Number: 15164274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown