MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA? TIBIA Ø11X270MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23411127S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the preoperative plan was to use a 360mm nail, but the surgeon was instructed to produce a 270mm nail during the surgery, so the 270mm nail was opened and prepared.However, the surgeon's understanding was that the nail was 370mm, and the nail was inserted deeply with a hammer to the patient tibia.This led to the anterior part of the tibia and the cartilage were scraped.+15mm end cap was inserted to the nail and the bone defects were filled with artificial bone.Damage of the anterior tibia and cartilage".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains in patient body.
Additional Manufacturer Narrative
Please note the corrections to section b2.The reported event could not be confirmed, since the device was not returned and no additional information was available.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instruction for use states that: ¿the correct selection of the fracture fixation appliance is extremely important.Implants can be available in different versions, varying for example in length, diameter, angle, right-hand and left-hand versions, material and number of drilled holes.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.¿ no indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the preoperative plan was to use a 360mm nail, but the surgeon was instructed to produce a 270mm nail during the surgery, so the 270mm nail was opened and prepared.However, the surgeon's understanding was that the nail was 370mm, and the nail was inserted deeply with a hammer to the patient tibia.This led to the anterior part of the tibia and the cartilage were scraped.+15mm end cap was inserted to the nail and the bone defects were filled with artificial bone.Damage of the anterior tibia and cartilage".

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø11X270MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18073287
• Report Number: 0009610622-2023-00388
• Device Sequence Number: 7815154
• Product Code: HSB
• UDI-Device Identifier: 07613327290493
• UDI-Public: 07613327290493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 23411127S
• Device Lot Number: K07E46D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian