MAUDE Adverse Event Report: CONMED LARGO HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO9350B

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the pro9350b, hall titan primecut+ oscillating saw battery hp, was used during an acl reconstruction on (b)(6) 2021 when it was reported, ¿during acl (knee) the new pro9350b lost the terminal part.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that a component of the device had fallen into the patient and was retrieved by hand.The procedure was completed as planned.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the pro9350b, hall titan primecut+ oscillating saw battery hp, was used during an acl reconstruction on (b)(6) 2021 when it was reported, ¿during acl (knee) the new pro9350b lost the terminal part.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that a component of the device had fallen into the patient and was retrieved by hand.The procedure was completed as planned.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Customer event ¿lost the terminal part¿ was confirmed based on device evaluation.The oscillator head fell off during testing.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed.(b)(4).Per the instructions for use, the user is advised to always inspect handpiece and accessories prior to use.Do not use damaged equipment.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the (b)(4), hall titan primecut+ oscillating saw battery hp, was used during an acl reconstruction on (b)(6) 2021 when it was reported, ¿during acl (knee) the new (b)(4) lost the terminal part.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that a component of the device had fallen into the patient and was retrieved by hand.The procedure was completed as planned.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 12890524
• MDR Text Key: 285169521
• Report Number: 1017294-2021-00363
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO9350B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic