MAUDE Adverse Event Report: STRYKER GMBH T2 FE RETRO NAIL LNG D11XL400; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-1140S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient came in around 7 months after first surgery and the nail broke right at the 6th most distal static hole.This led to a non-union and revision surgery to replace the broken nail.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since provided x-rays indicated nail breakage as well as the item received.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The device inspection revealed the following: the macroscopic appearance of the breakage surfaces identified the nail had broken in fatigue manner ¿ indicated by lines of rest and missing plastic deformation.The incipient crack had started at the smallest cross section at lateral in the posterior web and had progressed towards medial and experienced final separation in a residual fracture in both webs at medial.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.Medical information revealed the item had broken after more than 7 months of implantation.A medical review revealed the item had broken due to a very unstable area at the height of the distal metaphyseal part of the femur.The bone cavity widens and allows for movement/micromotion around the fracture line.The surgeon used a bollard screw to provide further stability and approximate the fracture lines.There is also plenty of screws to reduce the fracture lines in between the fragments and to provide stability.However, it did not work as the fatigue of the material appeared before consolidation of the fracture was achieved.There is some callus visible around the fracture zone, however, non-union has led to fatigue and breakage of the nail.If there was a reason for the breakage it is likely to be the unfavorable fracture pattern.Based on investigation, the root cause was attributed to a patient related issue.The event was caused by non-union.
Event or Problem Description
As reported: "patient came in around 7 months after first surgery and the nail broke right at the 6th most distal static hole.This led to a non-union and revision surgery to replace the broken nail.".

• Brand Name: T2 FE RETRO NAIL LNG D11XL400
• 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: 17366639
• Report Number: 0009610622-2023-00262
• Device Sequence Number: 6647429
• Product Code: HSB
• UDI-Device Identifier: 07613327293746
• UDI-Public: 07613327293746
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2339-1140S
• Device Catalogue Number: 23391140S
• Device Lot Number: K091BBD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG