MAUDE Adverse Event Report: UNKNOWN TAYLOR-SPATIAL-FRAME; PIN, FIXATION, THREADED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 11/24/2020

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2020, the patient underwent a revision due to non-union of smith and nephew taylor-spatial-frame.During the procedure.Starting guide wire was inserted using a lateral entry femoral nail approach 10 degrees lateral for the femoral anatomic axis.The opening step drill was used to open the canal over the reaming wire.Due to the patients hip and large soft tissue envelope, the opening drill lateralized the opening femoral entry hole.It is estimated the new entry angle was beyond 10 degrees.Ria2 assembly was inserted with a reamer head.When the reamer reached the medial wall, a small amount of advancement was achieved, but the reamer head levered against the bone and broke.The ria2 assembly was removed and bone collection was assessed.The surgeon needed more grail and a smaller reamer head was selected.The ria2 assemble was once again inserted.Further progress was made beyond the initial reamer path.Once again, when the reamer reached the medial wall, a small amount of advancement was achieved, but the reamer head levered against the bone and broke.The ria2 assembly was removed and bone collection was assessed with a satisfactory volume collected.The procedure was successfully completed with a fifteen to twenty (15-20) minute surgical delay.The patient status is unknown.(b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TAYLOR-SPATIAL-FRAME
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17526300
• MDR Text Key: 321149206
• Report Number: MW5133239
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: REAMER