MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ALIF DRILL UNIVERSAL JOINT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 03.30.10.1640

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

During an anterior lumbar interbody fusion procedure the tip broke off the medacta device.The surgeon attempted, but was unable to retrieve the tip from the bone.

• Brand Name: ALIF DRILL UNIVERSAL JOINT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; 3973 delp street; memphis TN 38118
• MDR Report Key: 11715667
• MDR Text Key: 246989266
• Report Number: 11715667
• Device Sequence Number: 1
• Product Code: LXH
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.30.10.1640
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA