MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. HUMERAL BODY TRIAL W/ DEFINITIVE LRG MOD; TEMPLATE

Model Number	DTL096008LRG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the humeral body trial w/ definitive lrg mod plastic broke off during extraction.It is unknown how was the procedure finished.No significant delay was reported.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H6:health effect - impact code.Section h3, h6: the product has not been received at the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified no similar reported events for this device nor 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.The complaint alleges no injury to the patient nor a delay during surgery.It was determined that the device likely contributed to the reported event as the most probable cause of the failure was wear and damage due to normal use.The rss definitive stem body trial is a reusable instrument expected to be used across multiple surgeries.It is used to evaluate the size and fit of the implantable devices to be used.The trial features a plastic socket which is fitted onto the stem implant while trailing.Repeated used of this instrument could caused the plastic socket to be worn and damaged over time.Additionally, the dhr/batch record review determined that the instrument associated with this complaint was manufactured and has been in service since 2015, further supporting normal wear and tear as the most probable cause.Based on this investigation, the need for corrective action is not indicated as no non-conformances 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: HUMERAL BODY TRIAL W/ DEFINITIVE LRG MOD
• Common Device Name: TEMPLATE
• 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: 15136788
• Report Number: 3002788818-2022-00056
• Device Sequence Number: 17491535
• Product Code: HWT
• UDI-Device Identifier: 10381780235415
• UDI-Public: 10381780235415
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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
• Device Model Number: DTL096008LRG
• Device Catalogue Number: DTL-0960-08LRG
• Device Lot Number: PM0324
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/30/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown