MAUDE Adverse Event Report: ARTHREX, INC. PUNCH, LARGE 2.75MM, 15 DEG UP CURVED; ACCESSORIES, ARTHROSCOPIC

Model Number PUNCH, LARGE 2.75MM, 15 DEG UP CURVED

Device Problems Component Missing (2306); Dull, Blunt (2407); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Device has a missing tip pin.The precise cause for a missing tip pin could not be determined.Tip pin was not returned or accounted for during evaluation/investigation process.Function test could not be performed due to the related condition.

Event Description

This is a conversion from cc183280, line 281969.An customer update was received which made a repair to a complaint.The customer stated the instrument does not close correctly and is blunt.No additional information as to what failure mode occurred was provided.There was no harm or adverse event for patient, operator or third party reported by the customer.Update 08-apr-2021: further information were provided that intra-operatively it was found that the instrument did not grip.The instrument was removed from the operating area, cleaned and sent for repair.The customer reported that the missing pin was not noticed either in the operating department or in the sterilization department.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Device has a missing tip pin.The precise cause for a missing tip pin could not be determined.Tip pin was not returned or accounted for during evaluation/investigation process.Function test could not be performed due to the related condition.

• Brand Name: PUNCH, LARGE 2.75MM, 15 DEG UP CURVED
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: vik bajnath ; 8009337001
• MDR Report Key: 11655796
• MDR Text Key: 247324512
• Report Number: 1220246-2021-02903
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867002968
• UDI-Public: 00888867002968
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/13/2021

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
• Device Operator: Health Professional
• Device Model Number: PUNCH, LARGE 2.75MM, 15 DEG UP CURVED
• Device Catalogue Number: AR-11210
• Device Lot Number: 62820
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1