MAUDE Adverse Event Report: CONMED LARGO LANZA; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	9391A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 9391a, 4.2mm x 13 cm lanza shaver blade, 6 ea, was being used during an unknown procedure on 4jun24 when it was reported, ¿the tip of the shaver blade came apart in the patients knee, the surgeon was able to retrieve the tip of the shaver blade, then confirmed it by taking a live xray with the mini c-arm.The surgery was delayed by about 20 minutes.".There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported 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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 9391a, 4.2mm x 13 cm lanza shaver blade, 6 ea, was being used during an unknown procedure on (b)(6) 2024 when it was reported, ¿the tip of the shaver blade came apart in the patients knee, the surgeon was able to retrieve the tip of the shaver blade, then confirmed it by taking a live xray with the mini c-arm.The surgery was delayed by about 20 minutes.".There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
D1 has been updated from short description to brand name.Manufacturer narrative: an evaluation of the returned used device, item 9391a found outer blade tip detached from the shaft.Root cause cannot be determined, however, based upon evaluation of the device, and ifu; a possible cause of this event could be applying excessive loading on the shaver blade or bur.A device history record (dhr) review found no abnormalities that would contribute to this reported event.A two-year lot history review shows a total of one (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of two complaints, regarding two 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 (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.Direct contact of the rotating cutting edge of shaver blades and burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices.If contact does occur, shaver blades can break, seize, or shed metal particles.Shaver blade or bur should be examined for damage and replaced if necessary.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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: LANZA
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 19559518
• Report Number: 1017294-2024-00074
• Device Sequence Number: 4851473
• Product Code: GFA
• UDI-Device Identifier: 30845854046184
• UDI-Public: (01)30845854046184(17)290424(10)1385594
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/05/2024

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 Catalogue Number: 9391A
• Device Lot Number: 1385594
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic