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

Catalog Number PRO7300B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Laceration(s) (1946)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

User's age is approximate age, in their (b)(6) as per reporter.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 customer reported that the device, pro7300b, was being used during right total knee replacement with mako on approximately (b)(6) 2021 when it was reported that the "blade came out during use.Injury to end user - dr.Assistant.No injury to patient." further assessment questioning found that the handpiece was being used to cut the patella and, on the 3rd, pass the blade dislodged from the handpiece and cut the assistant's hand.The assistant was assessed and returned to work later that day.There was no report of injury, medical intervention or hospitalization for the patient.And there was no report of medical intervention or hospitalization for the assistant.The procedure was completed with a 15-20-minute delay.The blade, 00507114200, will be listed as the concomitant device due to the reporter filing this report against the handpiece and we have no information to support that the blade malfunctioned in any way.This report is being raised on the basis of injury due to assistant's hand being cut.

Manufacturer Narrative

An evaluation of the returned device found that the oscillating head locking mechanism failed.The unit was last repaired and preventive maintenance performed on august 2020.The preventive maintenance was performed as part of repair order.The unit was repaired, evaluation completed, and final tested.The unit met all specifications.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 and found similar failure mode to this complaint; the previous service was performed in august 2020.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame (b)(4)devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised that prior to each use, perform the following: ensure all accessories are correctly and completely attached and perform the required preoperative functional tests for the equipment and accessories.Do not contact the moving parts on the handpiece.Injury to the operator may occur.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HALL50 OSCILLATING SAW BATTERY HPC
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11371920
• MDR Text Key: 242513197
• Report Number: 1017294-2021-00074
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRO7300B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 00507114200, OSCILLATOR BLADE, ME-92 COATED
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 50