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

Model Number	IMP-0926-030-02A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a combo inserter/impactor.M broke after being washed in spd.As this was noticed upon cleaning and sterilization activities, there was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H6: the product was received at the aus site for evaluation.The complaint was confirmed.The following investigative actions were performed.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified similar reported events for this device.No similar events were identified for the same product lot.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Visual inspection: determined that potential causes of the failure could include mishandling of the inserter during or after use.Evaluation of the returned device found that one arm of the inserter was broken off and missing.A definitive root cause could not be determined.The complaint alleges no injury to the patient nor a delay during surgery.The visual inspection did not indicate that the device failed to meet any manufacturing specifications.A determination of whether the device might have contributed to the reported event could not be made as a definitive root cause for the failure could not be determined.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.Additionally, due to the design of the instrument, the inserter may be broken if mishandled, such as by resting a heavy object on top of the device while the bottom is unsupported.The complaint description indicates that the device was observed to be broken while cleaning after a surgery.The most likely cause of the failure is combination of normal wear due to the device¿s age (manufactured in 2016) and handling during cleaning.Based on this investigation, the need for corrective action is not indicated as no non-conformance's or product deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• 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: 14506401
• Report Number: 3002788818-2022-00028
• Device Sequence Number: 14720959
• Product Code: HWA
• UDI-Device Identifier: 10381780355946
• UDI-Public: 10381780355946
• 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,Followup
• Report Date (Section B): 06/23/2022

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-0926-030-02A
• Device Catalogue Number: IMP-0926-030-02A
• Device Lot Number: 20806503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/23/2022
• Date Device Manufactured: 10/12/2016
• 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