MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. BASEPLATE/GLENOSPHERE INSERTER; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number INS-0990-861

Device Problems Fracture (1260); Separation Failure (2547)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during surgery, as the surgeon was impacting a 15 deg reverse baseplate into the glenoid, the threaded portion of one (1) baseplate/glenosphere inserter, broke off in the baseplate implant itself.The surgeon then proceeded to manually remove the baseplate.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Section h3, h6: the associated devices were returned and evaluated.The visual inspection of the baseplate/glenosphere inserter revealed found that the threaded tip of the instrument had been fractured off and lodged in the 15 deg augment baseplate full wedge.Additionally, the device had signs of indentations/wear on the top of the rod handle.During evaluation, the threaded tip from the baseplate/glenosphere inserter was unable to be removed from the 15 deg augment baseplate full wedge.Visual evaluation of the 15 deg augment baseplate full wedge did note some damage to the notch near where the threaded tip of the inserter is attached.It is likely this damage occurred when the baseplate/glenosphere inserter broke off.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 similar events 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 products 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: BASEPLATE/GLENOSPHERE INSERTER
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 18800759
• MDR Text Key: 336523003
• Report Number: 3002788818-2024-00029
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00885556812280
• UDI-Public: 885556812280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220847
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS-0990-861
• Device Lot Number: 22CNC0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 15 DEG AUGMENT BASEPLATE FULL WEDGE, LOT#:20530080.