MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, 5.5MM 13CM; SAW BLADE

Model Number	EXCALIBUR, 5.5MM 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy surgery metal shavings were produced with the devices.All fragments were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.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.***update, khe, (b)(6) 2023: 12 original packed devices were received.
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.
Additional Manufacturer Narrative
The complaint is not confirmed.Three boxes containing five, four, and three sealed ar-8550ex batch 15065835 were received for investigation.The reported failure device was not received for evaluation.No photos were provided.The method of bone preparation employed during the procedure, as well as the bone quality encountered, were not provided.The returned devices were visually inspected and noted no issues.Three randomly chosen returned samples were tested with the synergy resection shaver console ar-8305, the ar-8330f shaver handpiece, and water under normal use conditions to see if the issues(s) reported could be reproduced and no metal shavings were observed on the water.The functional test found that the inner tube rotates smoothly inside the outer tube.The reported failure is most likely caused by prying/leveraging the device against bone and/or hard tissue.

• Brand Name: EXCALIBUR, 5.5MM 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: 17413848
• Report Number: 1220246-2023-07335
• Device Sequence Number: 9025703
• Product Code: GFA
• UDI-Device Identifier: 00888867043817
• UDI-Public: 00888867043817
• 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): 10/13/2023

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, 5.5MM 13CM
• Device Catalogue Number: AR-8550EX
• Device Lot Number: 15065835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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