MAUDE Adverse Event Report: BIOMET ORTHOPEDICS, LLC ULTRA-DRIVE® TOOL; INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT

Model Number 423883

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

During operation of the ultra-drive® tool (tool for cement removal), the tip broke off.Good technique was used during operation.Physician was able to visualize the broken piece with c-arm.Healthcare providers were then able to remove the remaining cement as well as the cement plug and the cement restrictor using the ultra-drive and osteotomes.Healthcare providers would also noticed that of a small portion of the ultra-drive osteotome's tip broke off adjacent to the femur.Per the surgeon: there was nothing to be done differently, i was using the equipment per manufacturer's instructions.I attempted to remove the broken tip but could not get it out.I believe it is embedded in the bone.There should be no adverse outcomes due to the tip breakage.It was decided by surgeon to leave retained piece as it was deemed irretrievable.Ultradrive tool (ref #423883; lot #183140) 6.5mm straight knee osteotome.Biomet orthopedics.

• Brand Name: ULTRA-DRIVE® TOOL
• Type of Device: INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): BIOMET ORTHOPEDICS, LLC; 56 east bell dr.; po box 587; warsaw IN 46582
• MDR Report Key: 16101688
• MDR Text Key: 306701030
• Report Number: 16101688
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 423883
• Device Catalogue Number: 423883
• Device Lot Number: 183140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27740 DA
• Patient Sex: Male