MAUDE Adverse Event Report: CONMED LARGO ACROMIOPLASTY ELECTRODE, 165MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	C5012A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, a53-381-406, acromioplasty electrode, 165mm was being used during a shoulder arthroscopy on (b)(6) 2022 and ¿the black sheath of the a53-381-406 ((b)(4)) electrode disintegrates when the electrode is used in the patient and leaves many particles inside the shoulder.The surgeon has tried to remove as many particles as possible, but some remain in the joint.¿ there was no impact or injury to the patient or user.There was no medical intervention or any prolonged hospitalization for the patient.After further assessment it was found that the device that disintegrated was the a53-381-406 and ¿all fragments were removed with arthropump washing and suction¿.There was a 5 minute delay to the procedure.The patient is doing well.There was no allegation against the (b)(4), acromioplasty electrode and it will be listed as a concomitant device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.
Additional Manufacturer Narrative
Correction: b5 was corrected with the correct device.D4 was changed to correct catalog and lot numbers.Manufacturer narrative: reported event is inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.If the device is returned at a later date, the investigation may be updated and reanalyzed.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 1 report, regarding 1 device, 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 (b)(4).Per the instructions for use, the user is advised the following: use care when inserting into and withdrawing the electrode from a cannula to avoid the possibility of damage to the devices and/or injury to the patient.Do not insert, withdraw or touch the active tip of the electrode when power is being applied.This may result in an unintended surgical effect, injury, or device damage.Do not bury electrode tip and insulator in tissue.The electrode tip must be completely surrounded by conductive fluid when activated in order to avoid damage to the insulation.Do not pry or pull tissue using the device.Insulation may be damaged.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, c5012a, acromioplasty electrode was being used during a shoulder arthroscopy on 13apr22 and ¿the black sheath of the a53-381-406 (c5012a) electrode disintegrates when the electrode is used in the patient and leaves many particles inside the shoulder.The surgeon has tried to remove as many particles as possible, but some remain in the joint.¿ there was no impact or injury to the patient or user.There was no medical intervention or any prolonged hospitalization for the patient.After further assessment it was found that ¿all fragments were removed with arthropump washing and suction¿.There was a 5 minute delay to the procedure.The patient is doing well.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ACROMIOPLASTY ELECTRODE, 165MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: 14354960
• Report Number: 1017294-2022-00054
• Device Sequence Number: 14605761
• Product Code: HAW
• UDI-Device Identifier: 10845854030646
• UDI-Public: (01)10845854030646(17)260708(30)5(10)1186563
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K823424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 07/08/2026
• Device Catalogue Number: C5012A
• Device Lot Number: 1186563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4), ACROMIOPLASTY ELECTRODE.; (B)(4), ACROMIOPLASTY ELECTRODE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic