MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. LINER TRIAL HEIGHT +3MM; TEMPLATE

Catalog Number	TRL-0990-844-03H
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a reverse tsa surgery, the screw of the liner trial height +3mm broke and got stuck in the stem compactor size 1.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Additional information: d4, d9, h3 and h4.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Device returned and evaluated.Sections h3, h6 and h11 were updated.H11: results of investigation: from the associated devices only the liner trial returned, and the visual inspection revealed the device presents with the internally threaded plastic shaft fractured off and not returned.The screw was not returned with the partial device; the remainder of the device is scratched and scuffed from use on all surfaces.For the liner trial, a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the other device, the device batch number was not provided; thus, an evaluation of the manufacturing records could not be performed.For the liner trial, a review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.For the other device, a review of complaint history for the previous 12 months did not reveal similar events for the listed device.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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.These devices are reusable instruments 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 +3MM
• Common Device Name: 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23043541
• Report Number: 3002788818-2025-00092
• Device Sequence Number: 10054663
• Product Code: HWT
• UDI-Device Identifier: 00885556812877
• UDI-Public: 885556812877
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: TRL-0990-844-03H
• Device Lot Number: 22GNC0011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 10/21/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/08/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STEM COMPACTOR SIZE 1: COM-0990-808-01, UNKNOWN.
• Patient Sex: Unknown