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

Model Number	180-65-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem 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.
Additional 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
• Common Device Name: ALTEON 6.5MM SCREW, 30MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10055614
• Report Number: 1038671-2020-00291
• Device Sequence Number: 14131941
• Product Code: LPH
• UDI-Device Identifier: 10885862272669
• UDI-Public: 10885862272669
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2024
• Device Model Number: 180-65-30
• Device Catalogue Number: 180-65-30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 09/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR