MAUDE Adverse Event Report: CONMED LARGO MICRO 100 DRILL; INSTRUMENT, CUTTING, ORTHOPEDIC

Catalog Number	00505300900
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the 00505300900, micro 100 drill was being used on (b)(6) 2023 during a neurosurgery procedure and the ¿micro100 handpiece 00505300900 running at varying speeds without the lever being engaged.Not operating as required.Surgeon had to pause procedure - used another older handpiece to complete the surgery.¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.The procedure was completed with a 15 minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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.
Event or Problem Description
The customer reported that the 00505300900, micro 100 drill was being used on (b)(6) 2023 during a neurosurgery procedure and the "micro100 handpiece 00505300900 running at varying speeds without the lever being engaged.Not operating as required.Surgeon had to pause procedure - used another older handpiece to complete the surgery." there was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.The procedure was completed with a 15 minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
An evaluation of the returned device found that the issue was not able to be replicated.However, the poppet assembly did feel like it was rougher than usual and was slightly sticking.Foreign body found inside the handpiece which could have contributed.The problem seen in the video is possibly caused by a faulty/damage hose.The unit was repaired, evaluation completed and final tested.The unit met all specifications.The preventive maintenance was completed as part of this repair order.The service history was reviewed, and no prior data was found.A device history record review found a non-conformance, however, it was not related to the manufacture of the product.(b)(4).Per the instructions for use, the user is advised that prior to each use, inspect all equipment for proper operation, ensure all attachments, accessories and hoses are able to be correctly and completely attached to the handpiece, inspect pneumatic hoses for signs of wear or damage prior to use.Discontinue use and replace immediately if any signs of wear or damage are detected and check all equipment for any air or nitrogen leakage.If leakage is noticed, return for service.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Update: the country is listed as australia in e1.An evaluation of the returned device found that the issue was not able to be replicated.However, the poppet assembly did feel like it was rougher than usual and was slightly sticking.Foreign body found inside the handpiece which could have contributed.The problem seen in the video is possibly caused by a faulty/damage hose.The unit was repaired, evaluation completed and final tested.The unit met all specifications.The preventive maintenance was completed as part of this repair order.The service history was reviewed, and no prior data was found.A device history record review found a non-conformance, however, it was not related to the manufacture of the product.(b)(4).Per the instructions for use, the user is advised that prior to each use, inspect all equipment for proper operation, ensure all attachments, accessories and hoses are able to be correctly and completely attached to the handpiece, inspect pneumatic hoses for signs of wear or damage prior to use.Discontinue use and replace immediately if any signs of wear or damage are detected and check all equipment for any air or nitrogen leakage.If leakage is noticed, return for service.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 00505300900, micro 100 drill was being used on (b)(6) 2023 during a neurosurgery procedure and the ¿micro100 handpiece 00505300900 running at varying speeds without the lever being engaged.Not operating as required.Surgeon had to pause procedure - used another older handpiece to complete the surgery.¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.The procedure was completed with a 15 minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: MICRO 100 DRILL
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• 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: 18310014
• Report Number: 1017294-2023-00115
• Device Sequence Number: 20362263
• Product Code: HTZ
• UDI-Device Identifier: 10845854023518
• UDI-Public: (01)10845854023518(11)220106
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2024

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: 00505300900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 01/19/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/25/2024; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic