MAUDE Adverse Event Report: CONMED LARGO POWERPRO SMALL 2-TRIGGER PIN DRIVER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	PRO6232
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the pro6232, powerpro small 2-trigger pin driver, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿broken internal component fell off - pieces fell out of the front of the driver.¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device broke during surgery.One of three fragments fell into surgical site.The surgeon used his hand to remove the single fragment.The procedure was completed without any report of delay.This report is being raised due to the reported 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.
Additional Manufacturer Narrative
The device was not overdue for preventative maintenance.The shaft had confirmed failure and was broken.The root cause cannot be determined, however, based upon evaluation, and the ifu, a possible cause of this event was that the device was dropped and became damaged.A device history record (dhr) review was not conducted as the device has been in the field greater than 12 months.The service history was reviewed, and no previous data was found.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 devices, for this device family and failure mode.During this same time frame 593 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 0.01.Per the instructions for use, the user is advised the following: this equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment.Read and follow all warnings, precautionary notices and instructions.Handle all equipment carefully.If an attachment is dropped or damaged in any way, return it immediately for service.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the pro6232, powerpro small 2-trigger pin driver, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿broken internal component fell off - pieces fell out of the front of the driver.¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device broke during surgery.One of three fragments fell into surgical site.The surgeon used his hand to remove the single fragment.The procedure was completed without any report of delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: POWERPRO SMALL 2-TRIGGER PIN DRIVER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 17884715
• Report Number: 1017294-2023-00093
• Device Sequence Number: 7429622
• Product Code: HWE
• UDI-Device Identifier: 10845854036235
• UDI-Public: 10845854036235
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: PRO6232
• Device Lot Number: LAA02543
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic