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

Catalog Number	00507118100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.We will continue to monitor per regulatory requirements to help ensure 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, 00507118100, oscillator blade, 19.5 x 86 x 1.27 mm (.050"), was being used during a knee surgery procedure on an unknown date when it was reported, ¿most of the blade's break at the same spot.¿ further assessment found that the "tip of the blade broke in two (snapped)." all fragmentation was retrieved with pliers.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed with a 2-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 00507118100, oscillator blade, 19.5 x 86 x 1.27 mm (.050"), was being used during a knee surgery procedure on an unknown date when it was reported, ¿most of the blade's break at the same spot.¿.Further assessment found that the "tip of the blade broke in two (snapped)." all fragmentation was retrieved with pliers.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed with a 2-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: d4 lot number has been updated.Manufacturer narrative: the returned product was not previously used, still in the new condition.The package was found intact and not compromised.The complaint device was not returned; it appears that a sample device was provided.Examination of the returned new device, item 00507118100 found no issues with returned blade.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 (b)(4) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 31 complaints, regarding (b)(4) 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 not use saw blades to pry, remove bone grafts, or as a leverage point.Patient or user injury could occur.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.Avoid contact of blades and burs with cutting blocks, retractors or other instrumentation.Damage to blade, bur or instrumentation may occur.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• 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: 22051291
• Report Number: 1017294-2025-00053
• Device Sequence Number: 18461651
• Product Code: GFA
• UDI-Device Identifier: 10845854009086
• UDI-Public: (01)10845854009086(17)291106(10)1423881
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 00507118100
• Device Lot Number: 1423881
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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