MAUDE Adverse Event Report: CONMED LARGO 2.9MM STERLING CUDA, 6 EA; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	C9952A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
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 returned.
Event or Problem Description
The sales representative reported on behalf of the customer that the device c9952a, 2.9mm sterling cuda, 6 ea was being used on (b)(6) 2022 during a wrist scope procedure when it was reported ¿snapped in half during wrist scope.¿ further assessment found that ¿the shaver snapped while in the wrist but was picked up immediately.Patient was not injured." the procedure was completed with a few minutes of delay to open a new shaver.There was no reported injury, hospitalization or medical intervention for the patient.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 device c9952a, 2.9mm sterling cuda, 6 ea was being used on (b)(6) 2022 during a wrist scope procedure when it was reported ¿snapped in half during wrist scope.¿ further assessment found that ¿the shaver snapped while in the wrist but was picked up immediately.Patient was not injured." the procedure was completed with a few minutes of delay to open a new shaver.There was no reported injury, hospitalization or medical intervention for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction h10 item catalog number was a typo.Was mistakenly reported as s9952a and was changed to c9952a.Manufacturer narrative: reported event is confirmed.Customer complaint of the blade snapped in half during case was confirmed.Examination of returned used item c9952a confirms the reported problem and found the shaver inner blade tube broke off.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 5 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame 726,108 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 ifu, the user is advised that if shaver blade clogs, use conmed linvatec declogger (e9315) to declog shaver blade.Shaver blades or burs may also be declogged by removing the inner assembly of the shaver blade from the outer assembly and clearing any tissue from the window or aspiration hole.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 metals (wear), motor seizure and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Reported event is confirmed.Customer complaint of the blade snapped in half during case was confirmed.Examination of returned used item s9952a confirms the reported problem and found the shaver inner blade tube broke off.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 5 complaints, regarding 5 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 0.000007.Per the ifu, the user is advised that if shaver blade clogs, use conmed linvatec declogger (e9315) to declog shaver blade.Shaver blades or burs may also be declogged by removing the inner assembly of the shaver blade from the outer assembly and clearing any tissue from the window or aspiration hole.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 metals (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 sales representative reported on behalf of the customer that the device c9952a, 2.9mm sterling cuda, 6 ea was being used on 27jun22 during a wrist scope procedure when it was reported ¿snapped in half during wrist scope.¿ further assessment found that ¿the shaver snapped while in the wrist but was picked up immediately.Patient was not injured." the procedure was completed with a few minutes of delay to open a new shaver.There was no reported injury, hospitalization or medical intervention for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 2.9MM STERLING CUDA, 6 EA
• 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 rd; utica, NY 13502 ; 3152230184
• MDR Report Key: 15026058
• Report Number: 1017294-2022-00079
• Device Sequence Number: 14999332
• Product Code: GFA
• UDI-Device Identifier: 10845854012574
• UDI-Public: (01)10845854012574(17)270201(10)1224277
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2022

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: C9952A
• Device Catalogue Number: C9952A
• Device Lot Number: 1224277
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 08/25/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/19/2022; 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic