MAUDE Adverse Event Report: CONMED LARGO HALL50 OSCILLATING SAW BATTERY HPC; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO7300B

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/08/2021

Event Type  malfunction  

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.Device not yet received.

Event Description

The sales representative reported on behalf of the customer that the device, pro7300b, was being used on (b)(6) 2021 during a total knee arthroplasty procedure and ¿broke open during a surgery¿.There was no report of impact or injury to the patient.After further assessment, it was found there was a 30 minute delay to x-ray the patient to ensure no metal from the saw was left in the knee and the procedure was completed.Patient is ok.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The service history was reviewed and no data was found.The device history review found a non conformance but it is not related to the failure mode.A two-year review of complaint history revealed there has been a total of 27 complaints, regarding 30 devices, for this device family and failure mode.During this same time frame 6,490 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.005.Per the instructions for use, the user is advised the following: when using the powerpro sagittal saw attachment (pro2043), placing excessive bending or twisting force on the sagittal saw blade may cause the collet to open and release the saw blade.Do not use saw blades to pry, remove bone grafts, or as a leverage point.Patient or user injury could occur.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 device, (b)(6), was being used on (b)(6) 2021 during a total knee arthroplasty procedure and ¿broke open during a surgery¿.There was no report of impact or injury to the patient.After further assessment, it was found there was a 30 minute delay to x-ray the patient to ensure no metal from the saw was left in the knee and the procedure was completed.Patient is ok.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Correction: investigation findings changed from no findings available to fracture problem.H10 manufacturer narrative: changed from inconclusive to confirmed.Manufacturer narrative: update: reported event is confirmed.The device is not being returned but photographic evidence was provided that confirmed the reported problem.The service history was reviewed and no data was found.The device history review found a non conformance but it is not related to the failure mode.A two-year review of complaint history revealed there has been a total of 27 complaints, regarding 30 devices, for this device family and failure mode.During this same time frame (b)(4)devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: when using the powerpro sagittal saw attachment (pro2043), placing excessive bending or twisting force on the sagittal saw blade may cause the collet to open and release the saw blade.Do not use saw blades to pry, remove bone grafts, or as a leverage point.Patient or user injury could occur.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 device, pro7300b, was being used on (b)(6) 2021 during a total knee arthroplasty procedure and ¿broke open during a surgery¿.There was no report of impact or injury to the patient.After further assessment, it was found there was a 30 minute delay to x-ray the patient to ensure no metal from the saw was left in the knee and the procedure was completed.Patient is ok.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL50 OSCILLATING SAW BATTERY HPC
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 12490767
• MDR Text Key: 274789631
• Report Number: 1017294-2021-00339
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO7300B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: X-RAY.; X-RAY.; X-RAY.
• Patient Ethnicity: Non Hispanic