MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS RADIAL BROACH SIZE 2 RIGHT; INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM

Model Number	348169
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint sample was not returned for evaluation and insufficient information was provided to determine what portion or in what manner the part was broken.Previous investigations for similar instruments identified excessive force when impacting, normal wear and tear, and off-axis loading as potential causes for breakage or damage of the broach.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
A facility reported the right radial broach (size 2) of the freedom wrist arthroplasty system broke during impaction.The surgeon had to find a way to take out the broken part and used a graft tool to take it out of the radius.No patient injury; however a 30 minutes surgical delay was reported.
Additional Manufacturer Narrative
The part was returned for evaluation.Visual examination of the part identified that the post of the broach was broken off from the top face.The post appeared to have sheared from the top face at the point where the post joins the body of the broach.The shear featured little plastic deformation, indicating that the break was the result of a brittle overload fracture.The failure was confirmed.Based on the examination of the part as well as previous similar investigations, the failure may have been caused by: 1) subjecting the device to force exceeding the material strength, such as during impaction, 2) subjecting the device to transverse force at the post joint, such as by twisting or bending the broach, and 3) long-term wear.As the device was manufactured in 2015, normal wear and tear is further supported as a possible cause.

• Brand Name: RADIAL BROACH SIZE 2 RIGHT
• Common Device Name: INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 11547746
• Report Number: 1651501-2021-00005
• Device Sequence Number: 17048210
• Product Code: HTQ
• UDI-Device Identifier: 10381780278597
• UDI-Public: 10381780278597
• 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: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 348169
• Device Catalogue Number: 348169
• Device Lot Number: PM0333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1