MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, 3.8MM X 13CM; SAW BLADE

Model Number	EXCALIBUR, 3.8MM X 13CM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a meniscus refixation surgery it was noticed that the shrink tubing on the blade is irreparably damaged.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
Complaint allegation is confirmed.One unpackaged, excalibur, 3.8 mm x 13 cm, ar-8380ex / batch 15188000, was received for evaluation.Upon visual evaluation, the teflon on the inner tube was bunched on the proximal end.The distal tip of the inner tube was also corroded significantly.Function testing was not performed due to the damage to the device.Dfu-0215-eor1_fmt_en; f: precautions; 12 states: " if disassembly of straight devices is required to remove a clog, care must be taken to prevent damage to the teflon tubing on the inner tube during re-assembly." the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device, as the user damaged the shrink tubing likely by trying to reassemble it, thus causing it to bunch.

• Brand Name: EXCALIBUR, 3.8MM X 13CM
• Common Device Name: SAW BLADE
• 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: 18914148
• Report Number: 1220246-2024-01502
• Device Sequence Number: 12484158
• Product Code: GFA
• UDI-Device Identifier: 00888867043381
• UDI-Public: 00888867043381
• 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): 09/04/2024

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: EXCALIBUR, 3.8MM X 13CM
• Device Catalogue Number: AR-8380EX
• Device Lot Number: 15188000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2024
• 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