MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, CURVED, HL 4.2MM X 19CM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	EXCALIBUR, CURVED, HL 4.2MM X 19CM
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
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 during a rotator cuff surgery the device ar-6420cex (lot: 15104511) broke and became very hot.The device burned the patient's shoulder and surgeon's finger.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.
Event or Problem Description
***update 23-jul-2024: during a phone call the following additional information were made available.The right shoulder only on one portal got burned however the surgeon was not able to remember which of the portals.It was further reported that no cannulas were used during the procedure and the fluid management system ar-6475 with an arthrex tubing, either ar-6420 or ar-6425.It was further confirmed that all devices ar-8500obe, ar-8400bc and ar-6420cex failed during the same surgery, because the surgeon had to increase the pressure as the patient bone was very hard.The patient was treated with a normal bandage and ointment and it was further confirmed that the surgeon did not get burned.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-6420cex excalibur, curved, hl, 4.2 mm x 19 cm batch number 15104511, was received for evaluation.Based on the information provided and arthrex¿s evaluation, device misuse was determined to be the root cause for this event.Functional testing could not be conducted as the device was received in a broken state.Visual inspection confirmed that the device had split into two parts.The fracture was likely caused by the bending and prying of the device.Dfu-0215-eor1 states, "failure to use this device in accordance with the directions for use below may result in device failure, render the device unsuitable for its intended use, or compromise the procedure¿ and ¿excessive "side-loading" on the device during use does not improve cutting performance and, in extreme cases, will cause irreversible damage to the device." upon full examination, the bending and prying of the device resulted in the bending of both the inner and outer tubes.The evident bending and breakage of the tubes indicates that the device was subjected to forces excessive enough to render it nonfunctional.Dfu-0215-eor1 states, "irreversible damage to all devices will result if they are run without the flow of irrigation (dry)." if the device was used without irrigation, it may cause the device to become hot and may lead to a burn.Dfu-0215-eor1 states, "running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn." please refer to attachment 7 for the full dfu.The outer tube of both device fragments was measured in accordance with the applicable drawing.The diameter ø 0.165 ±.001 yielded measurements of 0.166 and 0.166 and were found to be within the device¿s specification.Due to the damage, it was not possible to measure the inner tube.The device's certificate of conformance indicates that both the inner and outer tubes have met the torque requirements of 3 lb/in for the 4.2mm curved, as specified in the applicable drawing.The most likely cause for the reported failure was most likely user error due to improper bone preparation, misaligned insertion, use of the device without irrigation, and/or prying/levering the device during insertion.

• Brand Name: EXCALIBUR, CURVED, HL 4.2MM X 19CM
• 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: jared engle ; 8009337001
• MDR Report Key: 19527580
• Report Number: 1220246-2024-05667
• Device Sequence Number: 12633267
• Product Code: GFA
• UDI-Device Identifier: 00888867039209
• UDI-Public: 00888867039209
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EXCALIBUR, CURVED, HL 4.2MM X 19CM
• Device Catalogue Number: AR-6420CEX
• Device Lot Number: 15104511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown