MAUDE Adverse Event Report: ARTHREX, INC. GRSPR,PNTD 2.75MM X 100MM STR W/SR HNDL; MANUAL INSTR, GENERAL SURGICAL

Model Number	GRSPR,PNTD 2.75MM X 100MM STR W/SR HNDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
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 02/04/2025, it was reported by a sales representative via (b)(4) that an ar-31700sr grasper jaw broke upon first use in surgery.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-31700sr serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted the moving jaw is broken in the down position.The most likely cause for the reported failure can be attributed to use error of the device due to prying/leveraging the device during use.
Event or Problem Description
Additional information was received on 02/17/2025: no pieces broke while in the patient.There was no case delay or added anesthesia administered.The case was completed using the same grasper from a different set.There were no adverse effects on the patient.This occurred during a posterior ankle scope procedure on (b)(6) 2025.

• Brand Name: GRSPR,PNTD 2.75MM X 100MM STR 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: 21410562
• Report Number: 1220246-2025-00541
• Device Sequence Number: 21168351
• Product Code: MDM
• UDI-Device Identifier: 00888867293557
• UDI-Public: (01)00888867293557(11)240520(10)15250816
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/03/2025

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,PNTD 2.75MM X 100MM STR W/SR HNDL
• Device Catalogue Number: AR-31700SR
• Device Lot Number: 15250816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2024
• 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