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

Model Number	IMP096006601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the glenosphere impactor mod broke when using to impact the glenosphere.It is unknwon how the procedure was completed.No delays reported.No patient complications reported.
Additional Manufacturer Narrative
The part has not yet been received and photographs were not provided, so the failure could not be confirmed.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.If the part is later returned to integra this investigation may be reopened and updated.Insufficient information was provided to determine what portion or in what manner the part was broken.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.According to previous investigations for similar instruments, the instrument damage may have been caused by rapid brittle fracture due to off-axis loading applied during impaction.If the part is later returned to integra this investigation may be reopened and updated.

• 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: 14603008
• Report Number: 3002788818-2022-00033
• Device Sequence Number: 5064445
• Product Code: HWA
• UDI-Device Identifier: 10381780245667
• UDI-Public: 10381780245667
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• 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: Health Professional
• Device Model Number: IMP096006601
• Device Catalogue Number: IMP-0960-066-01
• Was Device Available for Evaluation?: Yes
• 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 Age: 79 YR
• Patient Sex: Male