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

Model Number DTL-0960-08STD

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a total shoulder conversion to a reverse shoulder, one (1) humeral body trial w/ definitive std mod broke when fitting it over the stem.The place that broke off is the black plastic tip that covers over the stem that is implanted into the humerus and was stuck on top of the stem.It then had to be split in two with an elevator and removed with a kocher.The procedure was resumed, after a significant delay, with a change in the surgical technique.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Section h3, h6: the product has not been received at the aus site for evaluation, but photographs were provided.The reported event was confirmed.The following investigative actions were performed.- complaint history review: the complaint history review identified similar reported events for this device.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 a delay during surgery.As the device has not been returned for evaluation, it could not be determined whether the device contributed to the reported event.As the device has not been returned for evaluation, a definitive root cause could not be determined.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 collar which is fitted onto the top post of the stem implant while trialing.The plastic collar fits into a hole on the bottom of the trial and is secured to the trial by a dowel pin.Evaluation of the photograph provided by the customer found that the plastic collar on the trial had broken off from the socket of the trial.The complaint indicates that the broken collar remained stuck on the top post of the implanted stem and had to be removed using other instruments, causing a delay during surgery.The most likely cause for the reported event is wear due to normal use.Repeated used of the trial could cause 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 manufacturing 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.

Manufacturer Narrative

H3, h6: the complaint has been re-opened as the product has been received at the aus site for evaluation.The reported event was confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this device.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: visual examination of the part found that the rss definitive stem body trial was broken into one or more pieces.The failure was confirmed.The complaint alleges a delay during surgery.Visual evaluation of the rss definitive stem body trial found that the collar on the trial was broken off, the reported event was confirmed.The trial features a collar made from radel, a type of plastic, which is fitted onto the top post of the stem implant while trailing.The plastic collar fits into a hole on the bottom of the trial and is secured to the trial by a dowel pin.Evaluation of part as well as the photograph provided by the customer found that the plastic collar on the trial had broken off from the socket of the trial.The complaint indicates that the broken collar remained stuck on the top post of the implanted stem and had to be removed using other instruments.The most likely cause for the reported event is wear due to normal use.Repeated used of the trial could cause 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 manufacturing 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 STD MOD
• Type of Device: 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: 16372250
• MDR Text Key: 309491795
• Report Number: 3002788818-2023-00014
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00885556863718
• UDI-Public: 00885556863718
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DTL-0960-08STD
• Device Catalogue Number: DTL-0960-08STD
• Device Lot Number: PM0357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention