MAUDE Adverse Event Report: STRYKER GMBH CARBON TUBE, BLUE MONOTUBE TRIAX 20 X 250MM; COMPONENT, TRACTION, INVASIVE

Model Number 5150-2-411

Device Problem Device Slipped (1584)

Patient Problems Injury (2348); Malunion of Bone (4529)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: after application of a blue triax (femur, child) with carbon rod and two 4-pin holders, a pin holder on the rod shifted because it was loosened and the fracture healed with a malposition.Additionally reported: revision surgery necessary with plate osteotomy.

Event Description

As reported: after application of a blue triax (femur, child) with carbon rod and two 4-pin holders, a pin holder on the rod shifted because it was loosened and the fracture healed with a malposition.Additionally reported: revision surgery necessary with plate osteotomy.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.The device was actually received fully functional.No loosening was noticed.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: CARBON TUBE, BLUE MONOTUBE TRIAX 20 X 250MM
• Type of Device: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10208486
• MDR Text Key: 198100310
• Report Number: 0008031020-2020-01804
• Device Sequence Number: 1
• Product Code: JEC
• UDI-Device Identifier: 07613327078978
• UDI-Public: 07613327078978
• Combination Product (y/n): N
• PMA/PMN Number: K963614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5150-2-411
• Device Catalogue Number: 51502421
• Device Lot Number: BZFXA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 30