MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. LINER TRIAL HEIGHT +0MM; TEMPLATE

Catalog Number TRL-0990-844-00H

Device Problem Fracture (1260)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that, during a shoulder arthroplasty with aetos, after trialing and trying to remove the poly trial, the gleno size component came off first and left the gray poly thickness component attached to the trial meta stem.Upon using the t-20 driver to remove the humeral liner trial height +0mm, the silver screw that integrates into the meta stem broke from the cup.The screw remained in, but was able to be removed after about 25-30 seconds independently.This incident did not affect the outcome of the case.

Manufacturer Narrative

H10: internal complaint reference: case-(b)(4).

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the device screw channel was fractured off from the instrument.Some indentation marks and bending were present on the threads where the trial humeral liner threads in.Based on the visual evaluation and intended use of the device, a definitive root cause could not be determined.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LINER TRIAL HEIGHT +0MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18096611
• MDR Text Key: 328136545
• Report Number: 3002788818-2023-00094
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00885556812860
• UDI-Public: 885556812860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TRL-0990-844-00H
• Device Lot Number: 22GNC0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female