MAUDE Adverse Event Report: CONMED LARGO 13.5 X 25.5 X 0.4MM MICRO OSCILLATOR BLADE, CRESCENTIC; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5023-171
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
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, 00502317100, 13.5 x 25.5 x 0.4mm micro oscillator blade, crescentic was being used on (b)(6) 2022 during an ankle reconstruction procedure and ¿the blade snapped into two pieces while dr (b)(6) making a cut.Neither the doctor nor the patient was injured; one part of the blade stayed in the microfree handpiece and the other was lodged in the bone.¿ after further assessment it was found that the device fragments were completely retrieved with needle-nose clamps.The procedure was completed with a 1 minute delay while swapping out blades.There was no injury or impact to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the, 00502317100, 13.5 x 25.5 x 0.4mm micro oscillator blade, crescentic was being used on 14apr22 during an ankle reconstruction procedure and ¿the blade snapped into two pieces while dr k.Making a cut.Neither the doctor nor the patient was injured; one part of the blade stayed in the microfree handpiece and the other was lodged in the bone.¿ after further assessment it was found that the device fragments were completely retrieved with needle-nose clamps.The procedure was completed with a 1 minute delay while swapping out blades.There was no injury or impact to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event is confirmed.Customer complaint of the blade snapped was confirmed.Visual examination of the returned used, item 00502317100 confirms the reported problem and found blade broken off at the weld.Mc crescentic 13.5mm x 25.5mm x.4mm was detached from mc crescentic/intra-oral hub, modified at the weld joints.Both parts were returned for evaluation.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 21 reports, regarding 27 devices, for this device family and failure mode.During this same time frame 1,782,422 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 0.00002.Per the instructions for use, the user is advised the following: prior to each use, ensure all accessories are correctly and completely attached and perform the required preoperative functional tests for the equipment and accessories.Do not operate oscillating saw or reciprocating saw without a blade locked securely in place.Damage to the handpiece can occur.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 13.5 X 25.5 X 0.4MM MICRO OSCILLATOR BLADE, CRESCENTIC
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 14285621
• Report Number: 1017294-2022-00052
• Device Sequence Number: 6200019
• Product Code: GFA
• UDI-Device Identifier: 10845854006153
• UDI-Public: (01)10845854006153(17)260203(30)1(10)1147264
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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 Expiration Date: 02/03/2026
• Device Model Number: 5023-171
• Device Catalogue Number: 00502317100
• Device Lot Number: 1147264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic