MAUDE Adverse Event Report: ARTHREX, INC. SABRE, SJ 3.0MM 7CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	SABRE, SJ 3.0MM 7CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2022
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
On (b)(6) 2022, it was reported by a sales representative via email that an ar-7300sr sabre produced debridement of tissue in the patient while being used.Shavings were left in the joint.This was discovered during a wrist scope procedure.
Additional Manufacturer Narrative
The complaint is not confirmed based on the photo that the customer provided, which displays the sabre, no abrasion marks on the device were shown.However, without the return of the device for physical evaluation, the most likely cause of this failure is attributed to user error due to 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: SABRE, SJ 3.0MM 7CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16120517
• Report Number: 1220246-2023-06048
• Device Sequence Number: 14914516
• Product Code: GFA
• UDI-Device Identifier: 00888867041974
• UDI-Public: 00888867041974
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: SABRE, SJ 3.0MM 7CM
• Device Catalogue Number: AR-7300SR
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 06/08/2024
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown