MAUDE Adverse Event Report: ARTHREX, INC. SABRE, 5.0MM X 13CM; SAW BLADE

Model Number	SABRE, 5.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy, the plastic insulation on the shaft of two of the devices detached.At the end of the procedure, the surgeon found that one or more of the devices produced metal debris intraoperatively.There was no harm for patient, operator or third party.The surgery was finished successfully with a new reusable shaver.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.The complaint is confirmed.Two unpackaged ar-8500sr sabre, 5.0 mm x 13 cm, batch 10834671, were received for evaluation.Both devices were received disassembled.Upon visual inspection, the shrink tubing fep was damaged on both inner tubes.It was noted that white-like plastic contamination inside the outer tube, possibly from the fep shrink tube melted.Nicks and scratches were observed on the tip of the inner tube and outer tube tip.The observed condition is most likely the result of running the device without water.The most likely cause for the reported failure is a user error per dfu-0215-4 at revision 0.F.Precautions.5.Excessive ¿side-loading¿ on the device during use does not improve cutting performance and, in extreme cases will cause irreversible damage to the device.7.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).8.Running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn.10.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.

• Brand Name: SABRE, 5.0MM 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: emily shafer ; 8009337001
• MDR Report Key: 17246366
• Report Number: 1220246-2023-07013
• Device Sequence Number: 15161227
• Product Code: GFA
• UDI-Device Identifier: 00888867043886
• UDI-Public: 00888867043886
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/05/2024

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 Expiration Date: 03/31/2025
• Device Model Number: SABRE, 5.0MM X 13CM
• Device Catalogue Number: AR-8500SR
• Device Lot Number: 10834671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• 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