MAUDE Adverse Event Report: CONMED LARGO OSCILLATING SAW BLADE 19 X 1.19 X 90MM QTY 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	V190-119-90
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the (b)(4), oscillating saw blade was being used on an unknown date sometime during the 1st week of november, 2021 during a joint replacement procedure when it was reported ¿found broken metallic bit on table after saw blade use, confirmed missing pieces from saw blade.Recovered 2 pieces, can put entire blade back together, no missing piece.Fluoroscopy confirmed no metallic fb in patient.¿ there was no report of impact/injury to the patient.The procedure was completed without an alternate device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported event of ¿broken tangs on hand piece end of blade¿ is confirmed.The device will not be returned for evaluation; however, the provided photographic evidence exhibits the reported event 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 3 complaints, regarding 3 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 0.000009.Per the instructions for use, the user is advised the following: do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear) motor seizure and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The reported event of ¿broken tangs on hand piece end of blade¿ is confirmed.The device will not be returned for evaluation; however, the provided photographic evidence exhibits the reported event 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 3 complaints, regarding 3 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 0.000009.Per the instructions for use, the user is advised the following: do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear) motor seizure and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the v190-119-90,oscillating saw blade was being used on an unknown date sometime during the (b)(6), 2021 during a joint replacement procedure when it was reported ¿found broken metallic bit on table after saw blade use, confirmed missing pieces from saw blade.Recovered 2 pieces, can put entire blade back together, no missing piece.Fluoroscopy confirmed no metallic fb in patient.¿ there was no report of impact/injury to the patient.The procedure was completed without an alternate device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: OSCILLATING SAW BLADE 19 X 1.19 X 90MM 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13009816
• Report Number: 1017294-2021-00371
• Device Sequence Number: 19274009
• Product Code: GFA
• UDI-Device Identifier: 10845854021439
• UDI-Public: (01)10845854021439(17)251110(10)1126049
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 11/10/2025
• Device Model Number: V190-119-90
• Device Catalogue Number: V190-119-90
• Device Lot Number: 1126049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: X-RAY TAKEN 1ST WEEK OF (B)(6) 2021.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic