MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, SJ 3.0MM X 7CM; SAW BLADE

Model Number	DISSECTOR, SJ 3.0MM X 7CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2024
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.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 surgery the use of the shaver blade resulted in metal debris.There was no harm for patient, operator or third party reported.No further information received.Update dw 31-jan-2024: further information was provided that metal debris remained inside the patient's joint.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Two unpacked ar-7300ds dissector, sj, 3.0 mm x 7 cm batch/serial number (b)(6), were received for evaluation.As well as two packaged ar-7300ds dissector, sj, 3.0 mm x 7 cm batch/serial number (b)(6).The complaint allegation only reported one.Visual inspection found nicks around the edges of the outer tube windows.After removing the outer tubes, the inner tubes were inspected, and it was noted that there were lines and marks around the tip at the distal end of both devices.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.The most likely cause can be attributed to misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the screw during insertion.Per dfu-0215-7 at revision 0.Section 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.

• Brand Name: DISSECTOR, SJ 3.0MM X 7CM
• 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: 18645224
• Report Number: 1220246-2024-00777
• Device Sequence Number: 20615120
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: 00888867041943
• 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): 07/30/2024

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: DISSECTOR, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 15131085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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