MAUDE Adverse Event Report: ARTHREX, INC. PUNCH MENISCL R,2.75MM 15°RT CRVD SFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	PUNCH MENISCL R,2.75MM 15°RT CRVD SFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-11392 was received for investigation.Functional testing identified that the jaws were unresponsive to trigger movements, indicating that the shear pin within the handle had broken.The observed condition is consistent with user-applied excessive force to the trigger.
Event or Problem Description
On 01/18/2022, it was reported by a distributor via (b)(4) that a ar-11392 punch has a broken clamp.This was discovered during an unknown time, with no patient effect.

• Brand Name: PUNCH MENISCL R,2.75MM 15°RT CRVD SFT
• 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: 19373627
• Report Number: 1220246-2024-03670
• Device Sequence Number: 20759001
• Product Code: NBH
• UDI-Device Identifier: 00888867003200
• UDI-Public: 00888867003200
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: PUNCH MENISCL R,2.75MM 15°RT CRVD SFT
• Device Catalogue Number: AR-11392
• Device Lot Number: 70334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown