MAUDE Adverse Event Report: EXACTECH, INC. ALTEON 6.5MM SCREW, 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number ALTEON 6.5MM SCREW, 25MM

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: alt xle lnr ntrl g4 36 (cat# 01-030-40-0436 / serial# (b)(6) ).The intraoperative alteon screw seating difficulty reported was likely the result of the angle of the screws, which may have led to contact between the screws and the cup while inserting, preventing the screws from fully seating and leading to incomplete seating of the liner.However, this cannot be confirmed as the devices were not returned for evaluation.The most probable root cause associated with the reported event of "difficult to position¿ is associated with users experiencing difficulty or uneasiness to deploy a device, device component, or both, to a specified location.Furthermore, the most probable root cause associated with the reported event of "disassembled / misassembled" is associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.).

Event Description

As reported, during surgical use, basically doing a total hip on a patient, after placing the cup surgeon had issues getting the acetabular screws to sit down.Liner then wouldn't fully seat, after pulling the liner we could see indentations on it where the screws were pushing on it.He had to burn the liner and remove his screw fixation to get the liner to seat.Essentially had to abandon screw fixation to get a liner to seat.Once the screws were removed, the liner was able to be seated.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and images received.The device is not available for evaluation due to the devices were thrown away.

• Brand Name: ALTEON 6.5MM SCREW, 25MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16800950
• MDR Text Key: 313950931
• Report Number: 1038671-2023-00806
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10885862272652
• UDI-Public: 10885862272652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141797NDAN/
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2023

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
• Device Operator: Health Professional
• Device Model Number: ALTEON 6.5MM SCREW, 25MM
• Device Catalogue Number: 180-65-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female