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	Foreign Body In Patient (2687)
Date of Event	05/04/2023
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 5/18/2023, it was reported by a sales representative via phone that an ar-3638ds fibertak disposables straight kit had an issue.During a labral repair procedure on (b)(6)2023, when the drill was inserted through the guide, they were cycling it and came back out, and the drill gun came off the actual drill, it was loose.It torqued the drill and broke the top of the flute inside the patient's glenoid.The anchor was never inserted.The drill bit could not be removed, and the surgeon deemed it safe to leave it inside the glenoid.X-rays were taken and will be provided via email.The doctor used a pushlock with an unknown part and lot number to complete the procedure successfully with no patient harm.Additional information has been requested.On 5/24/2023, the sales representative stated via phone that the broken drill had been discarded.On 5/24/2023, the sales representative also sent a picture of an x-ray via email and stated that the lot number of the ar-3638ds fibertak disposables straight kit had not been recorded.The procedure was completed using an ar-2923bc suture anchor, biocomposite pushlock, with lot number 15044351.
Additional Manufacturer Narrative
Complaint confirmed.The photo provided confirms that the tip of the drill broke off in the patient.The most likely cause of this can be attributed to prying/leveraging the device during use.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 17097581
• Report Number: 1220246-2023-06875
• Device Sequence Number: 16621237
• Product Code: LXH
• UDI-Device Identifier: 00888867287440
• UDI-Public: 00888867287440
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/20/2023

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 Model Number: FIBERTAK DISPOSABLES STRAIGHT KIT
• Device Catalogue Number: AR-3638DS
• Device Lot Number: 15044351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/20/2023
• 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