MAUDE Adverse Event Report: ARTHREX, INC. GRSPR,MINI,2.75 MM 15°UP CRV W/SR HNDL; MANUAL INSTR, GENERAL SURGICAL

Model Number	GRSPR,MINI,2.75 MM 15°UP CRV W/SR HNDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems-06675726 that an ar-11910sr grasper, mini straight tip was broken and no further information provided.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, ar-11910sr, mini grasper, straight tip, 15° up curved, was received for investigation.Visual inspection noted that the grasper tip was damaged/misaligned.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to wear and tear caused by extended usage in the field¿device manufacture date 2016.

• Brand Name: GRSPR,MINI,2.75 MM 15°UP CRV W/SR HNDL
• Common Device Name: MANUAL INSTR, GENERAL 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: jared engle ; 8009337001
• MDR Report Key: 20453421
• Report Number: 1220246-2024-08131
• Device Sequence Number: 7045282
• Product Code: NBH
• UDI-Device Identifier: 00888867003859
• UDI-Public: (01)00888867003859(11)161205(10)78262
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: GRSPR,MINI,2.75 MM 15°UP CRV W/SR HNDL
• Device Catalogue Number: AR-11910SR
• Device Lot Number: 78262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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