MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER, 4.0MM X 13CM; SAW BLADE

Model Number	BONE CUTTER, 4.0MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rotator cuff surgery the device ar-8400bc (lot: 15213860) broke.No fragments of the broken device remained inside the patient.The surgery was finished successfully with new devices with the same part number.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 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
Additional information.The complaint allegation was confirmed.One unpackaged ar-8400bc bone cutter, 4.0 mm x 13 cm batch number 15213860, was received for evaluation.Functional testing could not be conducted as the device was received in a broken state.Upon visual inspection, it was determined that the device was damaged.The inner tube had ruptured, and the outer tube was bent.Additionally, it was observed that the hub had been disassembled.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.Dfu-0215-eor1_fmt_en.E.Warnings.5.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.F.Precautions.7.Excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).
Event or Problem Description
Update 23-jul-2024: during a phone call the following additional information were made available.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.

• Brand Name: BONE CUTTER, 4.0MM 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: jared engle ; 8009337001
• MDR Report Key: 19588688
• Report Number: 1220246-2024-05592
• Device Sequence Number: 7214363
• Product Code: GFA
• UDI-Device Identifier: 00888867043466
• UDI-Public: 00888867043466
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BONE CUTTER, 4.0MM X 13CM
• Device Catalogue Number: AR-8400BC
• Device Lot Number: 15213860
• Was Device Available for Evaluation?: Yes
• 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: 06/21/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2024
• 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