MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALTEON 6.5MM SCREW, 30MM

Model Number 180-65-30

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, during a procedure on this (b)(6) female patient, the surgeon broke off the screw head from the screw body during insertion.It was very hard bone and the torque of trying to seat the screw into the acetabular cup caused the screw head to break off.The broken screw head was removed however the screw body was left inside the patient.The body of the screw was left inside the patient past the hole of the already seated acetabular cup.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: (h3) the evaluation noted that the revision was likely the result of an axial torque and a bending moment created by attempting to drive the screw into the patient¿s hard bone that may not have been fully drilled, leading to high stresses and ultimate fracture.However, this cannot be confirmed because the screw was not available for evaluation.No information provided in the following section(s): a4, a5, and b6.

• Brand Name: ALTEON
• Type of Device: ALTEON 6.5MM SCREW, 30MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10055614
• MDR Text Key: 196087882
• Report Number: 1038671-2020-00291
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10885862272669
• UDI-Public: 10885862272669
• Combination Product (y/n): N
• PMA/PMN Number: K141797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180-65-30
• Device Catalogue Number: 180-65-30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR