MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. HUMERAL HEAD GLENOSPHERE IMPACTOR; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	IMP-0990-835
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an aetos shoulder system procedure, the tip of one (1) humeral head glenosphere impactor broke.The tip did not fall inside the wound.The procedure was resumed, without any delay, using the same device.Patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
Section h3, h6: this event was investigated by the quality department, and it was found that a gap was present between the back plane of the radel tip where it interfaces to the metal shaft connection point.The root cause of this event was identified as a design transfer that missed the identification of a critical to quality feature.Drawing was updated to correct the absence of critical to quality feature.A review of complaint history based on the historical data revealed similar events for the listed batch.Each similar event was investigated together and reached the same conclusion.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.At this time, we have evidence to conclude that the product failed to meet specifications at the time of manufacture.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.
Additional Manufacturer Narrative
This event was investigated by the quality department, and it was found that a gap was present between the back plane of the radel tip where it interfaces to the metal shaft connection point.The root cause of this event was identified as a design transfer that missed the identification of a critical to quality feature.Drawing was updated to correct the absence of critical to quality feature.A review of complaint history based on the historical data revealed similar events for the listed batch.Each similar event was investigated together and reached the same conclusion.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.At this time, we have evidence to conclude that the product failed to meet specifications at the time of manufacture.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: HUMERAL HEAD GLENOSPHERE IMPACTOR
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 18988069
• Report Number: 3002788818-2024-00045
• Device Sequence Number: 8530573
• Product Code: HSD
• UDI-Device Identifier: 00885556811870
• UDI-Public: 885556811870
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• 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,Followup
• Report Date (Section B): 08/27/2024

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-0990-835
• Device Lot Number: 22JNC0010
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 04/19/2024; 08/22/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/24/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown