MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. MACHINED, HUMERAL HEAD/GLENOSPHERE IMPACTOR; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	IMP-0990-835M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a total shoulder arthroplasty procedure, while impacting the glenosphere one (1) machined, humeral head/glenosphere impactor broke.No plastic pieces were in the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
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.

• Brand Name: MACHINED, HUMERAL HEAD/GLENOSPHERE IMPACTOR
• 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: 17663510
• Report Number: 3002788818-2023-00062
• Device Sequence Number: 6207633
• Product Code: KWS
• UDI-Device Identifier: 00885556811870
• UDI-Public: 885556811870
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/24/2024

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-0990-835M
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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