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

Model Number	FIBERTAK DISPOSABLES STRAIGHT KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Insufficient Information (4580)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
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 (b)(6) 2023, it was reported by a sales representative via sems that an ar-3638ds knotless fibertak¿ disposable kits drill broke.This occurred during a shoulder arthroscopy labral repair on (b)(6) 2023 when the drill broke off in the patient's glenoid, a new kit was immediately opened and the case was completed.There was no additional information provided.
Event or Problem Description
Additional information provided on 02/15/2023, it was reported that the broken drill bit could not be retrieved.The broken fragment was buried in the glenoid and the only way to get it out would be to remove half of the patients glenoid.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-3638ds serial/batch number (b)(6) was received for investigation.Functional testing was not performed.Visual evaluation found that the flute of the drill was broken off at the tip.The fragments generated during the event were not returned for analysis.The cause remains undetermined as the method used to prepare the bone as well as the bone quality encountered were not provided.

• Brand Name: FIBERTAK DISPOSABLES STRAIGHT KIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16485035
• Report Number: 1220246-2023-06381
• Device Sequence Number: 15143270
• Product Code: LXH
• UDI-Device Identifier: 00888867287440
• UDI-Public: 00888867287440
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: FIBERTAK DISPOSABLES STRAIGHT KIT
• Device Catalogue Number: AR-3638DS
• Device Lot Number: 14310144
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown