MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5055S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the patient had a gamma3 operation about a year and a half ago.Now the nail is broken.The nail has now been removed and a t2 alpha recon was inserted (b)(6)2022." upon product return, one locking screw was also found broken.Additionally, the patient had pain in her hip, a ct-scan was performed and it was noticed that the nail was broken.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the identification of the device was confirmed based on the catalog # and the lot # marked.The locking screw is broken apart, the missing fragment was not returned for evaluation.The typical characteristics of a fatigue fracture could be identified.The origin of the fracture was seen on the edge of the surface, there is a fatigue zone with a smooth surface and progression lines over the fracture surface, with a shear lip on the left side where the fracture final occurred.The shiny surface on one side indicates that the fragments rubbed against each other after the breakage.The relevant dimensions were verified during the investigation and no deviation from the specification could be detected.The time of implantation (18 months) and the fatigue fracture observed indicate that the breakage was probably related to a bone mal-union or non-union, which also led to the breakage of the related nail.Based on the investigation, the root cause was attributed to a patient related issue.Possible non-union or mal-union of the bone has most probably complicated the healing, leading to the fracture, as the implant was not able to overtake the load of the patient anymore.No information related to the patient or the patient's activity nor x-rays of the fracture were received.Therefore, it cannot be confirmed that bone mal-union or non-union led to the fracture.Furthermore, nothing can be stated regarding the bone condition of the patient and if the post-operative instructions were followed.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.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 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: 15721332
• Report Number: 0009610622-2022-00482
• Device Sequence Number: 17954762
• Product Code: HSB
• UDI-Device Identifier: 04546540202529
• UDI-Public: 04546540202529
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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 Expiration Date: 10/31/2025
• Device Model Number: 1896-5055S
• Device Catalogue Number: 18965055S
• Device Lot Number: K04AA79
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 65 KG