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

Catalog Number	PRO6232
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
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 on (b)(6) and the ¿pin drivers fall apart into the patient today the pin drivers fell apart and there is no way to fix them.¿.Per further assessment it was found that "the inside component that holds the pin in the pin driver fell out".The component was retrieved from the surgical site.¿.There was no report of impact or injury to the patient or user.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.
Event or Problem Description
Update: per information received on 5jun24, the pins used with the pro6232 "was a smith & nephew total shoulder pin (74013490 23ksm0767) i believe it is said to be 3.2mm (1.25").It worked in their old pro6232, but those had to be like 10 years old and maybe wore out enough to fit that pin.I also got a diameter sizing chart and that pin did not fit into the 1.25 hole.I think the pin is a smidge larger than what they said.".The sales representative reported on behalf of the customer that the pro6232, powerpro small 2-trigger pin driver was being used on (b)(6) 2024 and the "¿pin drivers fall apart into the patient today¿the pin drivers fell apart and there is no way to fix them." per further assessment, it was found that "the inside component that holds the pin in the pin driver fell out".The component was retrieved from the surgical site." there was no report of impact or injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device was not overdue for preventative maintenance.The shaft was confirmed to be broken and the pin was slightly larger than the required 0.125" specification; however, r&d team reviewed returned products and found no manufacturing changes or top-level parts changed.The root cause cannot be determined, however, based upon the evaluation, and the ifu, the likely cause of this event was from damage sustained during use.The service history was reviewed, and no prior data was found.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.(b)(4).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 marked on the product and included in this insert.Use only associated hall surgical and conmed accessories and attachments as defined in the description of each attachment in the manual.Handle all equipment carefully.If an attachment is dropped or damaged in any way, return it immediately for service.Prior to each use, inspect all equipment for proper operation and ensure all attachments and accessories are correctly and completely attached to the handpiece.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: POWERPRO SMALL 2-TRIGGER PIN DRIVER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMEN
• 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: 19258679
• Report Number: 1017294-2024-00048
• Device Sequence Number: 2582364
• Product Code: HWE
• UDI-Device Identifier: 10845854036235
• UDI-Public: (01)10845854036235(11)240124
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/24/2024

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: PRO6232
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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: SMITH & NEPHEW TOTAL SHOULDER PIN
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic