MAUDE Adverse Event Report: ARTHREX, INC. GLENOID SCRAPETTE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GLENOID SCRAPETTE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9601 serial/batch number 6402211102 was received for evaluation.Functional testing was not performed due to device being damaged.A visual inspection revealed that the cutting hook is broken, which has deformed the geometry.The reported condition is most likely caused by overstressing a device damaged naturally and inevitably due to normal wear or aging.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 06/25/2024, it was reported by a sales representative via sems(b)(4) that an ar-9601 glenoid scrapette broke it and cracked apart.This was a result of wear and tear.

• Brand Name: GLENOID SCRAPETTE
• 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: 19762187
• Report Number: 1220246-2024-06791
• Device Sequence Number: 15580044
• Product Code: LXH
• UDI-Device Identifier: 00888867287679
• UDI-Public: 00888867287679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/29/2024

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: GLENOID SCRAPETTE
• Device Catalogue Number: AR-9601
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown