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

Catalog Number PRO2033

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product code (b)(4): at time of filing, although expected, the reported device has not been received into conmed¿s complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer in australia reported issues with the (b)(6), powerpro high speed drill attachment, lot/sn (b)(4), that (b)(6) hospital experienced on (b)(6) 2021.Information received indicates that, during use in an ortho procedure, the high speed drill attachment came apart.It was in the sterile field at the time, and it was confirmed bits of the device did fall inside the surgical site.The medical staff performed an x-ray to ensure no components were left in patient.It is noted there was no impact or injury to the patient and the procedure was successfully completed with no delay.Although requested, no clarification has been made available at this time.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence, as although the pieces were removed, they did fall into the patient.

Event Description

The customer in (b)(6) reported issues with the pro2033, powerpro high speed drill attachment, lot/sn (b)(4), that (b)(6) hospital experienced on (b)(6) 2021.Information received indicates that, during use in an ortho procedure, the high speed drill attachment came apart.It was in the sterile field at the time, and it was confirmed bits of the device did fall inside the surgical site.The medical staff performed an x-ray to ensure no components were left in patient.It is noted there was no impact or injury to the patient and the procedure was successfully completed with no delay.Although requested, no clarification has been made available at this time.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence, as although the pieces were removed, they did fall into the patient.

Manufacturer Narrative

Additional product code hsz : at time of filing, although expected, the reported device has not been received into conmed¿s complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Investigation of the customer's complaint is confirmed.An evaluation of the returned device found that the rear housing came apart due to insufficient loctite or none at all.The unit is overdue for preventive maintenance.The service history was reviewed, and no data was found.A review of the dhr confirmed the manufacturing date and found no abnormalities that would contribute to this issue.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Please note however, because this is a reusable device, the potential number of uses is not considered in this occurrence rate.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also, per the ifu, the user is advised that prior to each use, inspect all equipment for proper operation and ensure attachments and accessories are correctly and completely attached to the handpiece.The most probable cause to lack of loctite is operator related during manufacturing.There have been no other similar issues in the last two years; therefore, no further action is necessary at this time.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer in (b)(6) reported issues with the pro2033, powerpro high speed drill attachment, lot/sn (b)(6) , that (b)(6) hospital experienced on (b)(6) 2021.Information received indicates that, during use in an ortho procedure, the high speed drill attachment came apart.It was in the sterile field at the time, and it was confirmed bits of the device did fall inside the surgical site.The medical staff performed an x-ray to ensure no components were left in patient.It is noted there was no impact or injury to the patient and the procedure was successfully completed with no delay.Although requested, no clarification has been made available at this time.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence, as although the pieces were removed, they did fall into the patient.

Manufacturer Narrative

H11: corrected data: d2: additional product code hab, hwe, hsz, get, gey g3 510k corrected from k032607 to exempt.H10: investigation of the customer's complaint is confirmed.An evaluation of the returned device found that the rear housing came apart due to insufficient loctite or none at all.The unit is not overdue for preventive maintenance.The service history was reviewed, and no data was found.A review of the dhr found a non-conformance, but it is not related to the complaint failure.(b)(4).Please note however, because this is a reusable device, the potential number of uses is not considered in this occurrence rate.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also, per the ifu, the user is advised that prior to each use, inspect all equipment for proper operation and ensure attachments and accessories are correctly and completely attached to the handpiece this issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer in australia reported issues with the (b)(4), powerpro high speed drill attachment, lot/sn (b)(6), that (b)(6) hospital experienced on (b)(6) 2021.Information received indicates that, during use in an ortho procedure, the high speed drill attachment came apart.It was in the sterile field at the time, and it was confirmed bits of the device did fall inside the surgical site.The medical staff performed an x-ray to ensure no components were left in patient.It is noted there was no impact or injury to the patient and the procedure was successfully completed with no delay.Although requested, no clarification has been made available at this time.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence, as although the pieces were removed, they did fall into the patient.

• Brand Name: POWERPRO HIGH SPEED DRILL ATTACHMENT
• Type of Device: 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: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12983160
• MDR Text Key: 285165922
• Report Number: 1017294-2021-00366
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO2033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic