MAUDE Adverse Event Report: ARTHREX, INC. PROBE, HOOK 4.8 MM TIP, 220 MM LONG; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PROBE, HOOK 4.8 MM TIP, 220 MM LONG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
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
It was reported that ar-10030 sn: (b)(6) has a broken-off tip.There was no harm for patient, operator or third party reported.No further information received.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Visual inspection identified the tip at the distal end of the shaft of the probe - hook, 220 mm shaft, 4.8 mm tip, w/5.0 mm markings, had broken off.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Manufactured in 2020.

• Brand Name: PROBE, HOOK 4.8 MM TIP, 220 MM LONG
• 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: 18131310
• Report Number: 1220246-2023-08714
• Device Sequence Number: 7790003
• Product Code: LXH
• UDI-Device Identifier: 00888867002388
• UDI-Public: 00888867002388
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/27/2024

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: PROBE, HOOK 4.8 MM TIP, 220 MM LONG
• Device Catalogue Number: AR-10030
• Device Lot Number: 11403968
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown