MAUDE Adverse Event Report: CONMED LARGO POWERPRO; DRILL, BONE, POWERED

Catalog Number	PRO2033
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D1 additional product code: hsz 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 pro 2033, powerpro high speed drill attachment was being used on (b)(6) 2024 during a podiatry case and ¿a high speed drill attachment broke apart during a case today.Multiple pieces landed in the patient.¿.There was no impact or injury for the patient or user.Per further assessment it was found that the fragments were retrieved from the patient.The procedure was completed with an alternate high speed drill attachment and a delay of a half hour to an hour.The patient is "recovering and there was no extended hospitalization".The pro 8500sb, hall microfree mini-driver will be listed as a concomitant device and there was no allegation against it.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 pro2033, powerpro high speed drill attachment was being used on (b)(6) 2024 during a podiatry case and ¿a high speed drill attachment broke apart during a case today.Multiple pieces landed in the patient¿.There was no impact or injury for the patient or user.Per further assessment it was found that the fragments were retrieved from the patient.The procedure was completed with an alternate high speed drill attachment and a delay of a half hour to an hour.The patient is "recovering and there was no extended hospitalization".The pro8500sb, hall microfree mini-driver will be listed as a concomitant device and there was no allegation against it.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
D1: additional product code: hsz manufacturer narrative: reported event of ¿high speed drill attachment broke apart¿ was confirmed.The device has not been returned to date, but photographic evidence has been provided.A root cause cannot be determined, however, based upon photographic evidence of the device, and the ifu; a possible cause of this event could be that a bur guard was not used to provide the proper stabilization.The service history was reviewed and no data was found.A device history record (dhr) review found a non-conformance; however, it was not related to the manufacture of the product.A two-year review of complaint history revealed there has been a total of 3 reports, regarding 3 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 the following: always inspect for bent, dull or damaged accessories (i.E., burs, cutting wheels) before each use.Do not attempt to straighten or sharpen.Do not use if damaged.After use, dispose of properly according to facility guidelines.Prior to each use, inspect all equipment for proper operation and ensure attachments and accessories are correctly and completely attached to the handpiece.Do not use the high-speed drill attachment without the appropriate bur guard and a bur of the proper length.The tip of the bur guard should cover the safe line on the bur shaft.Without the stabilization that the proper guard provides, the bur can break and be propelled with great force.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: POWERPRO
• Common Device Name: DRILL, BONE, POWERED
• 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: 19849494
• Report Number: 1017294-2024-00088
• Device Sequence Number: 15092420
• Product Code: DZI
• UDI-Device Identifier: 10845854028384
• UDI-Public: (01)10845854028384(11)230130
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: PRO2033
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRO8500SB, HALL MICROFREE MINI-DRIVER.; PRO8500SB, HALL MICROFREE MINI-DRIVER.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic