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

Catalog Number	IMP-0926-030-02A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during tsa surgery, one (1) tss head cutting template rod.2.5; one (1) rss reamer guide body insrtr/extrctr and one (1) reamer guide body inserter/extractor mod were broke during the case.No x-rays available, items were not broken inside patient and no pieces were left in patient.The procedure was resumed, after a non-significant delay, with the same devices.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.Visual evaluation of the fin-lock combo inserter/impactor found that a piece of the reusable instrument was fractured off.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Potential root causes are wear due to normal use and excessive force.The fin-lock combo inserter/impactor is a reusable instrument expected to be used across multiple surgeries.During normal use, the inserter grips the fin-lock glenoid implant and secures it to the glenoid impactor handle.It places the glenoid implant in the correct location and then protects the implant while the handle is being impacted with a mallet to seat the implant.Therefore, the inserter may fail if excessive force is applied during impaction or may weaken over time due to normal wear.Based on this investigation, the need for corrective action is not indicated.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.
Event or Problem Description
It was reported that, during tsa surgery, one (1) combo inserter/impactor.M broke during the case.No x-rays available, item did not broke inside patient and no pieces were left in patient.The procedure was resumed, after a non-significant delay, with the same device.No injury was reported as a consequence of this issue.

• Brand Name: COMBO INSERTER/IMPACTOR. M
• 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: 18490767
• Report Number: 3002788818-2024-00005
• Device Sequence Number: 11685224
• Product Code: HWA
• UDI-Device Identifier: 00885556860748
• UDI-Public: 00885556860748
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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-0926-030-02A
• Device Lot Number: UNKNOWN
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/07/2024
• 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