MAUDE Adverse Event Report: ARTHREX, INC. GRSPR, ALGR, 2.75, NR W/FLUSHPORT; MANUAL INSTR, GENERAL SURGICAL

Model Number	GRSPR, ALGR, 2.75, NR W/FLUSHPORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is defective.Also, there was no harm for patient, operator or third party reported.It will be processed as repair, not as complaint.Update (b)(6) 18-oct-2024: further information was provided that during the reported event has occurred during a surgery.The surgeon tried to remove a free joint body from the joint.The forceps broke off during the first attempt.Update (b)(6) 24-oct-2024: further information was provided that the shear pin inside the handle broke outside the patient.The reported event occurred during a knee arthroscopy with anterior cruciate ligament plastic.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different plier.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-11600nrf alligator hook tip grasper lot number: 15212779 was received for investigation.Visual evaluation of the device noted no problems with the exterior of the device.Functional testing was performed by actuating the device to manipulate the jaws.It was found that the grasper was not able to be opened and closed as intended.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• Brand Name: GRSPR, ALGR, 2.75, NR W/FLUSHPORT
• 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: 20522669
• Report Number: 1220246-2024-08235
• Device Sequence Number: 15473316
• Product Code: MDM
• UDI-Device Identifier: 00888867273047
• UDI-Public: (01)00888867273047(11)240227(10)15212779
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/27/2025

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, ALGR, 2.75, NR W/FLUSHPORT
• Device Catalogue Number: AR-11600NRF
• Device Lot Number: 15212779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown