MAUDE Adverse Event Report: CONMED CORPORATION MICROPOWER SAGITTAL SAW, PERMANENT LEVER; ARTHROSCOPE

Catalog Number 00602102200

Device Problem Failure to Cut (2587)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/15/2020

Event Type  Injury  

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 pro7200se was being used during a mandibulectomy hemi with reconstruction on (b)(6) 2020 when a blade disengaged from the handpiece.A second handpiece was used, and the same failure occurred with the accessory blade.A third handpiece was used; however, the user felt that this handpiece did not have the same failure effect as the previous two handpieces.Due to the previous failed devices the user chose to change technique and use a chisel/osteotome to complete the procedure.This resulted in the patient sustaining a pathological fracture due to the chiseling.The user stated that this would cause the patient extended hospitalization.The current status of the patient is unknown.This report is being raised on the basis of injury due to the fracture sustained by the patient being an indirect result of the handpiece failure.

Event Description

The sales representative reported on behalf of the customer that the 00602102200 was being used during a mandibulectomy hemi with reconstruction on (b)(6) 2020 when a blade disengaged from the handpiece.A second handpiece was used, and the same failure occurred with the accessory blade.A third handpiece was used; however, the user felt that this handpiece did not have the same failure effect as the previous two handpieces.Due to the previous failed devices the user chose to change technique and use a chisel/osteotome to complete the procedure.This resulted in the patient sustaining a pathological fracture due to the chiseling.The user stated that this would cause the patient extended hospitalization.The current status of the patient is unknown.This report is being raised on the basis of injury due to the fracture sustained by the patient being an indirect result of the handpiece failure.

Manufacturer Narrative

Correction: previously the reporter reported the wrong catalog number device that was used in this event.All information for the incorrect device, pro7200se, has been changed to the correct device, 00602102200.All corrections below are in regards to this change: manufacturer narrative: an evaluation of the returned device found that the safe slide is worn, and the blade did come loose while cutting through a 2x4 of wood.The unit however met ground bond, speed and all other tests.The most likely cause of this failure is lack of preventive maintenance, the device is supposed to be returned every 12-month for servicing.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 of this device was reviewed and found no data.At the time of this report the device is 87 months of age.(b)(4).Per the instructions for use, the user is advised the following: maintenance schedule: the micropower handpieces and attachments shall be returned every 12 months for servicing.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MICROPOWER SAGITTAL SAW, PERMANENT LEVER
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 10372814
• MDR Text Key: 202701527
• Report Number: 1017294-2020-00342
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K070233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00602102200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR