MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. GLENOSPHERE CON TRIAL 2MM MOD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	TRL096002C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up, it was noticed that the glenosphere con trial 2mm mod was broken.Procedure was performed, without any delay, with the same device.No patient complications were reported.
Additional Manufacturer Narrative
The part has not yet been received, but photographs were provided.Evaluation of the photos identified that the center post of the glenosphere trial was broken off from the body of the line.The failure was confirmed.If the part is later returned to integra this investigation may be reopened and updated.According to risk documentation for the rss system, probable causes for instrument breakage or damage include inadequate design, inadequate or incorrect surgical technique, and normal wear.As the part associated with this complaint was manufactured in 2014, wear is further supported as the most likely cause for the failure of the center post.If the part is later returned to integra this investigation may be reopened and updated.

• Brand Name: GLENOSPHERE CON TRIAL 2MM MOD
• 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: 14602213
• Report Number: 3002788818-2022-00031
• Device Sequence Number: 20375733
• Product Code: KWS
• UDI-Device Identifier: 10381780235897
• UDI-Public: 10381780235897
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K130050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

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: Other
• Device Model Number: TRL096002C
• Device Catalogue Number: TRL096002C
• Device Lot Number: PM0317
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/06/2022
• 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