MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5045S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the identification of the returned screw was confirmed based on the catalog # and the lot # marked.Parts of the thread are flattened.The implant is broken apart at approximately 21 mm from the tip, the fragment was not returned.The typical characteristics of a fatigue fracture could be identified on the breakage surface.The origin of the crack was at the right corner, there is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture and then we have a shear lip on the left side, where the final fracture occurred.The breakage of the locking screws and the thread flattening observed indicate that high axial load was applied on the implant, which is considered as patient behavior related.The screw failure observed after 5 months of implantation is fully related to the nail breakage.Both failures are a consequence of excessive load applied to the implant, related to the patient high activity (hiking) and the reported pseudarthrosis and delayed bone consolidation.However, as x-rays were not received, it was not possible to make any statement on the bone condition of the patient.Based on investigation, the root cause was attributed to a patient related issue.The failure was most probably caused by the high activity of the patient following the surgery and the reported delayed bone consolidation and pseudarthrosis.As a reminder, a nail will be subjected to a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.The affected implant is designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labelling.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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
Patient experienced pain and lameness when walking, which required revision surgery.There was a delay in consolidation, pseudarthrosis but even in these conditions it is only 5 months since placement so in my opinion the nail should hold more than that.Upon product return, two locking screws were found broken.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 16239837
• Report Number: 0009610622-2023-00018
• Device Sequence Number: 6306823
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: 04546540202505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: 1896-5045S
• Device Catalogue Number: 18965045S
• Device Lot Number: K07D0F6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 66 KG