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

Catalog Number	INS-0990-861
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an rsa procedure, one (1) baseplate/glenosphere inserter broke inside a 10 deg full wedge baseplate.The screw thread broke off inside the baseplate.The procedure was resumed using a s+n back-up device.It is unknown if there was a surgical delay.
Event or Problem Description
It was reported that, during an rsa procedure, one (1) base plate/glenosphere inserter broke inside a 10 deg full wedge baseplate.The screw thread broke off inside the baseplate.No pieces fell inside the wound.The procedure was resumed using a s+n back-up device.
Additional Manufacturer Narrative
H2: additional information ¿b5¿.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.Visual evaluation of the baseplate/glenosphere inserter found that the threaded tip of the instrument had been fractured off into the 10 deg augment baseplate.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 able to be removed from the 10 deg augment baseplate.Visual evaluation of the 10 deg augment baseplate did note some damage (knicks/scratches) to the sides of the implant.Some damage to the porous surface as visible, this is most likely from attempted implantation and subsequent removal, although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the baseplate/glenosphere inserter.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 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: BASEPLATE/GLENOSPHERE INSERTER
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 18983890
• Report Number: 3002788818-2024-00044
• Device Sequence Number: 16867573
• Product Code: KWS
• UDI-Device Identifier: 00885556812280
• UDI-Public: 885556812280
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• 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): 05/02/2024

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: INS-0990-861
• Device Lot Number: 22CNC0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 04/26/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/01/2024; 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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
• Patient Sex: Unknown