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

Model Number	5150-2-411
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Injury (2348); Malunion of Bone (4529)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10208486
• Report Number: 0008031020-2020-01804
• Device Sequence Number: 16667901
• Product Code: JEC
• UDI-Device Identifier: 07613327078978
• UDI-Public: 07613327078978
• Combination Product (Y/N): N
• PMA/510(K) Number: K963614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR
• Patient Weight: 30