MAUDE Adverse Event Report: CONMED LARGO POWERPRO SAGITTAL SAW ATTACHMENT; SAW, POWERED, AND ACCESSORIES

Model Number	PRO2043
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes are: hwe, hsz, get, gey and dzi.Manufacture 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 or Problem Description
The sales representative reported on behalf of the customer that the pro2043, powerpro sagittal saw attachment, was used during a trochleaplastic procedure on (b)(6) 2022 when it was reported, ¿during surgery the sawblade became loose from the attachment and fell to the floor.The operating room staff put on a new sawblade and that¿s when on of the staff realized that a small piece of locking spike was in the wound of the patient.It was removed of course.A hall50 saw was used, probably a loaner due to service.According to operating room staff it has happened before, that the sawblade becomes loose, but not to the extent that the saw attachment brakes.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The reporter stated that the procedure was prolonged, which could cause infection, while obtaining another device; however, the amount of time is not known, and there was no report of the patient being diagnosed with infection.The procedure was completed with the use of an alternate pro2043 device.Further assessment questioning found that the component was removed from the patient using tweezers.The customer also advised that they did not feel this was a serious event.The patient¿s current status is listed as ¿good¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The driver assembly pin was broken.Additional information provided indicates the technician disassembled the part for eag analysis.This attachment is approximately 16 months old.No noted workmanship or assembly issues with this attachment.Complaint verified that a pin had broken off and was missing as stated in the complaint.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.A two-year review of complaint history revealed there has been a total of 30 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 do not use the high speed drill attachment without the appropriate bur guard and a bur of the proper length.The tip of the bur guard should cover the safe line on the bur shaft.Without the stabilization that the proper guard provides, the bur can break and be propelled with great force.Prior to each use, perform the following: ensure all accessories are correctly and completely attached.Refer to section ¿2.2 assembly/installation instructions¿.Always inspect for bent, dull or damaged blades or drill bits before each use.Do not attempt to straighten or sharpen.Do not use if damaged.After use, dispose of properly.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the pro2043, powerpro sagittal saw attachment, was used during a trochleaplastic procedure on (b)(6) 2022 when it was reported, ¿during surgery the sawblade became loose from the attachment and fell to the floor.The or staff put on a new sawblade and that¿s when on of the staff realized that a small piece of locking spike was in the wound of the patient.It was removed of course.A hall50 saw was used, probably a loaner due to service.According to or staff it has happened before, that the sawblade becomes loose, but not to the extent that the saw attachment brakes¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The reporter stated that the procedure was prolonged, which could cause infection, while obtaining another device; however, the amount of time is not known, and there was no report of the patient being diagnosed with infection.The procedure was completed with the use of an alternate pro2043 device.Further assessment questioning found that the component was removed from the patient using tweezers.The customer also advised that they did not feel this was a serious event.The patient¿s current status is listed as ¿good¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: POWERPRO SAGITTAL SAW ATTACHMENT
• Common Device Name: 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: 14406330
• Report Number: 1017294-2022-00060
• Device Sequence Number: 5564300
• Product Code: HAB
• UDI-Device Identifier: 10845854028407
• UDI-Public: (01)10845854028407(11)201207
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: PRO2043
• Device Catalogue Number: PRO2043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic