MAUDE Adverse Event Report: CONMED LARGO 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	00507118100
Medical Device Problem Codes	Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the 00507118100, 19.5 x 86 x 1.27mm (.050 inch) oscillator blade, qty,5, was being used during a total knee procedure on (b)(6) 2023, when it was reported ¿blade tooth broke off and middle tooth bent¿.Further assessment questioning found that the fragment was retrieved with the use of forceps.The procedure was completed without delay.There was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of their customer that the 00507118100, 19.5 x 86 x 1.27mm (.050 inch) oscillator blade, qty,5, was being used during a total knee procedure on (b)(6) 2023 when it was reported ¿blade tooth broke off and middle tooth bent.¿.Further assessment questioning found that the fragment was retrieved with the use of forceps.The procedure was completed without delay.There was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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.A two-year lot history review shows a total of 2 complaints for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised to always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.Do not stall handpieces, damage can occur.Continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the 00507118100, 19.5 x 86 x 1.27mm (.050 inch) oscillator blade, qty,5, was being used during a total knee procedure on 21jun23 when it was reported ¿blade tooth broke off and middle tooth bent.¿.Further assessment questioning found that the fragment was retrieved with the use of forceps.The procedure was completed without delay.There was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device was received in opened original sterile packaging; lot number was verified.Visual inspection found all teeth present however, the left edge-most tooth is bent.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.A two-year lot history review shows a total of 2 complaints for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised to always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.Do not stall handpieces, damage can occur.Continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17320501
• Report Number: 1017294-2023-00066
• Device Sequence Number: 15090159
• Product Code: GFA
• UDI-Device Identifier: 10845854009086
• UDI-Public: (01)10845854009086(17)280415(10)1312215
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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: 00507118100
• Device Catalogue Number: 00507118100
• Device Lot Number: 1312215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 09/26/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 07/18/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic