MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS TIBIAL IMPACTOR; ANKLE REPLACEMENT

Model Number	MJU361T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has ben initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A physician reported that while impacting mju361t tibial impactor, the tip broke inside the implant's tibial keel.The surgeon tried to recover the broken piece inside the tibial keel, however, the part was not recovered.An x-ray was taken, but the part could not be accessed in the tibial keel.The physician did not encounter any difficulty during surgery due to the patient¿s physiology.There was no report of patient injury and no surgical delay.
Additional Manufacturer Narrative
The tibial impactor was received for evaluation: dhr review: a review of the manufacturing records identified no issues or problems which could have caused or contributed to the failure mode alleged by this complaint.Failure analysis: visual examination of the returned part found that the tip of the impactor was broken off and missing.The broken tip was not included in the shipment.The failure was confirmed.The most likely root cause for the instrument damage is off-axis loading during impaction.
Event or Problem Description
N/a.

• Brand Name: TIBIAL IMPACTOR
• Common Device Name: ANKLE REPLACEMENT
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13343319
• Report Number: 1651501-2022-00001
• Device Sequence Number: 4074002
• Product Code: HWA
• UDI-Device Identifier: 10381780366867
• UDI-Public: 10381780366867
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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: MJU361T
• Device Catalogue Number: MJU361T
• Device Lot Number: 16A225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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