MAUDE Adverse Event Report: ARTHREX, INC. RASP, TUNNEL/NOTCHPLASTY; MANUAL INSTR, GENERAL SURGICAL

Model Number	RASP, TUNNEL/NOTCHPLASTY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ankle surgery the tip of the device broke off.All parts were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1282 tunnel/notchplasty rasp serial/batch number (b)(6) was received for evaluation.Functional testing was not performed because the device's tip was broken off.A visual inspection revealed that the device's tip was broken off.The most likely cause of the reported and observed failure of the device is user error, specifically applying excessive side-loading on the device during use.

• Brand Name: RASP, TUNNEL/NOTCHPLASTY
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 20651465
• Report Number: 1220246-2024-08493
• Device Sequence Number: 12432667
• Product Code: NBH
• UDI-Device Identifier: 00888867006997
• UDI-Public: (01)00888867006997(11)231215(10)43212350
• 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): 01/31/2025

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: RASP, TUNNEL/NOTCHPLASTY
• Device Catalogue Number: AR-1282
• Device Lot Number: 43212350
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2023
• 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