MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. GLENOSPHERE IMPACTOR MOD

Catalog Number	IMP-0960-066-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a shoulder surgery, while impacting the glenosphere on the first strike of the glenosphere impactor mod the plastic bumper cracked and broke into several pieces.All pieces were removed and the wound was irrigated to ensure no pieces were left in the wound the surgery was completed, without any delay, with a s+n back-up device.No injuries were reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.Visual evaluation of the glenosphere impactor found that the radel impactor on the reusable instrument was broken off.Additionally, the device showed significant signs of wear.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.Based on visual evaluation, and nature of the device, the most probable cause for the reported event is wear due to normal use.The glenosphere impactor is a reusable instrument expected to be used across multiple surgeries.The intended use of the glenosphere impactor is to absorb forces exerted on the glenosphere, an implantable component of the reverse shoulder system, during impaction to prevent damage to the implant.The tip of the glenosphere impactor is made with radel, a durable plastic material.Therefore, the plastic impactor of the device may fail after prolonged use or if subjected to excessive force, such as during impaction.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: GLENOSPHERE IMPACTOR MOD
• Common Device Name: IMPACTOR
• 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: 18395430
• Report Number: 3002788818-2023-00116
• Device Sequence Number: 14186141
• Product Code: HWA
• UDI-Device Identifier: 00885556863923
• UDI-Public: 00885556863923
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: IMP-0960-066-01
• Device Lot Number: UV1220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2018
• 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