MAUDE Adverse Event Report: CONMED LARGO 25.4 X 95 X 1.27MM (.050INCH) OSCILLATOR BLADE, 5 EA; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	00507112400
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that (b)(6) 25.4 x 95 x 1.27mm (.050inch) oscillator blade, 5 ea, was being used during a hip prosthesis procedure on (b)(6)2024 when it was reported ¿one of the tooth of the blade broke while engraving the bone.Broken piece fallen into the operatory field but completely removed.¿.There was no report of injury, medical intervention, or prolonged hospitalization for the patient.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.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 customer reported that 00507112400, 25.4 x 95 x 1.27mm (.050inch) oscillator blade, 5 ea, was being used during a hip prosthesis procedure on (b)(6) 2024 when it was reported "one of the tooth of the blade broke while engraving the bone.Broken piece fallen into the operatory field but completely removed." there was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Visual examination of returned used blade, item 00507112400 found broken teeth.A broken tooth was not returned for evaluation.Examination was performed and could not find any issue with critical dimensions.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event is that this is a technique dependent device and the most likely cause of this suspected failure is user related, excessive force, lateral/side loading, and/or stalling of the device, was used that caused the blade to break 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.(b)(4).Per the instructions for use, the user is advised to avoid contact of blades with cutting blocks, retractors or other instrumentation.Damage to blade or instrumentation may occur.Metal fragments may cause injury to patient or user.Do not use saw blades to pry, remove bone grafts, or as a leverage point.Do not apply excessive bending or twisting force to blade.Patient or user injury may 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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 25.4 X 95 X 1.27MM (.050INCH) OSCILLATOR BLADE, 5 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 road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18940250
• Report Number: 1017294-2024-00034
• Device Sequence Number: 17849127
• Product Code: GFA
• UDI-Device Identifier: 10845854000328
• UDI-Public: (01)10845854000328(17)280913(10)1338017
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: 00507112400
• Device Lot Number: 1338017
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic