MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DISPOSABLES STRAIGHT KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FIBERTAK DISPOSABLES STRAIGHT KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 14th november 2023, it was reported by a sales rep.Via email that an ar-3638ds, knotless fibertak¿ dispoable kit, straight, tip of the drill bit was snapped off upon completion of drilling for a knotless fibertak anchor (ar-3636) in the glenoid.This was discovered during use in a right shoulder laterjet procedure and capsular closure procedure on (b)(6) 2023.The procedure was completed using a second disposable kit without disruption and patient harm however it was not confirmed if the broken drill bit was removed from patient.It was then noted on (b)(6) 2023, that the patient will be returned for surgery date(to be confirmed) for anchor and drill bit removal.X.23/11/2023 - the sales rep.Provided images of the needle of ar-3638ds which was removed by dr (b)(6) from the patient on (b)(6) 2023 at (b)(6) hospital.27/11/2023 - another sales rep., (b)(4), had a closer look at the drill bit and believes the small joint could be the reason for the breakage.He asked if there could be an investigation with inc why this weak point in the drill bit exists.
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
Additional information: d9, g3, h6.The complaint allegation is confirmed.Based on the customer-provided photo, which displays an x-ray showing the lodged alleged drill bit.However, without the return of the device for physical evaluation, the cause cannot be confirmed.The bone quality of the patient was not specified.The most likely cause of this condition is the excessive force used to pry and/or leverage the device.The cause remains misuse.

• Brand Name: FIBERTAK DISPOSABLES STRAIGHT KIT
• 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: 18307664
• Report Number: 1220246-2023-09342
• Device Sequence Number: 6783747
• Product Code: LXH
• UDI-Device Identifier: 00888867287440
• UDI-Public: 00888867287440
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/10/2024

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: FIBERTAK DISPOSABLES STRAIGHT KIT
• Device Catalogue Number: AR-3638DS
• Device Lot Number: 15071435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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