MAUDE Adverse Event Report: ARTHREX, INC. FLEXIBLE DRILL, FIBERTAK, 1.8MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	FLEXIBLE DRILL, FIBERTAK, 1.8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/1/2022, it was reported by a sales representative via email that an ar-3636 knotless fibertak inserter broke off during insertion.All fragments were retrieved, and case was completed with another arthrex anchor.This was discovered during a procedure on (b)(6) 2022.An additional 20 minutes were added to the case due to device breaking.Additional information received on 12/1/2022: a total of (2) ar-3636 knotless fibertak inserters broke inside the patient and all fragments were retrieved.Due to the case being delayed for 20 minutes, additional anesthesia was administered to the patient.Also, surgeon had difficulty inserting the anchor through the drill sleeve of an ar-3610nd-2 flexible 1.8mm drill, an ar-3610ctc curved fibertak spear, and (2) ar-3610ctc-2 tight curved fibertak spear.This was discovered during a labral repair procedure.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: FLEXIBLE DRILL, FIBERTAK, 1.8MM
• Common Device Name: POWERED SURG ORTHOPEDIC 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: jared engle ; 8009337001
• MDR Report Key: 19499288
• Report Number: 1220246-2024-05414
• Device Sequence Number: 18124123
• Product Code: HWE
• UDI-Device Identifier: 00888867358683
• UDI-Public: 00888867358683
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 06/10/2024

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: FLEXIBLE DRILL, FIBERTAK, 1.8MM
• Device Catalogue Number: AR-3610ND-2
• Device Lot Number: 14955073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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