MAUDE Adverse Event Report: ARTHREX, INC. SLOTTED SPEAR, FIBERTAK, REUSABLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SLOTTED SPEAR, FIBERTAK, REUSABLE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
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 12/21/2023, it was reported by a sales representative via sems (b)(4) that an ar-3610st slotted fibertaks tip bent.This occurred during a case where they were able to complete the procedure.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-3610st serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the device's bent tip.Upon visually evaluating the device, it was noted that the tip was bent.The most likely causes for this type of occurrence are prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: SLOTTED SPEAR, FIBERTAK, REUSABLE
• 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: 18533376
• Report Number: 1220246-2024-00388
• Device Sequence Number: 20776594
• Product Code: LXH
• UDI-Device Identifier: 00888867354289
• UDI-Public: 00888867354289
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/10/2024

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: SLOTTED SPEAR, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610ST
• Device Lot Number: 0072222
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown