MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. COMBO INSERTER/IMPACTOR. XS

Model Number	IMP-0926-030-00A
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
Additional Manufacturer Narrative
The part has not yet been returned for evaluation and photographs were not provided, so the failure could not be confirmed.According to risk documentation for the fin-lock system, potential causes of instrument damage or breakage include inadequate design, inadequate or incorrect surgical technique, and normal wear and tear.If the part is later returned to integra this investigation may be reopened and updated.As the part was not returned for investigation, a definitive root cause could not be found.Previous investigations identified possible root causes of mishandling of the device, resulting in breakage, as well as inadequate design or wear and tear.If the part is later returned, this complaint may be reopened and an investigation conducted.
Event or Problem Description
It was reported that, during surgery, the combo inserter/impactor.Xs broke off when inserting the tin lock glenoid.It is unknown how the procedure was completed.No delays reported.No patient complications reported.

• Brand Name: COMBO INSERTER/IMPACTOR. XS
• 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: 14602386
• Report Number: 3002788818-2022-00032
• Device Sequence Number: 5077183
• Product Code: HWA
• UDI-Device Identifier: 10381780355922
• UDI-Public: 10381780355922
• 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,Company Representative
• 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: IMP-0926-030-00A
• Device Catalogue Number: IMP-0926-030-00A
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female