MAUDE Adverse Event Report: STRYKER GMBH 4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX 20MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	5150-3-070
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.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The x-rays were received and reviewed by stryker's medical expert.The medical statement regarding this case is the following : "the issue is that there is a very oblique fracture line in the mid-shaft region.The child has, beneath other diagnosis, severe contracts on the muscles and stiff joints due to the amc.Child has been pretreated before the fracture with epiphysiodesis of the distal growth plate, probably to enable positioning in a wheelchair and handling.The fixation is not foreseen to hold this position with continuous traction due to the contracts, therefore it would have been advisable to position at least one screw in the fracture region to ensure the reposition of the fracture." moreover, the device was released in 2005, and has been fulfilling its task since, which lead to its normal wear.The lifetime of the device is not specified, but as stated in the cleaning and sterilization guide : ¿ stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.Based on the above-mentioned observations the case could be classified as user-related.
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
A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.
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.

• Brand Name: 4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX 20MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10208376
• Report Number: 0008031020-2020-01803
• Device Sequence Number: 2273159
• Product Code: KTT
• UDI-Device Identifier: 07613327072822
• UDI-Public: 07613327072822
• Combination Product (Y/N): N
• PMA/510(K) Number: K910483
• 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,Followup
• Report Date (Section B): 11/23/2020

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: 5150-3-070
• Device Catalogue Number: 51503070
• Device Lot Number: K14306
• 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: 08/20/2020; 10/29/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/16/2020; 11/24/2020
• 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