MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X420MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35301420S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "broke my thigh bone on (b)(6) 2023 and pin was inserted.Functioned normally for a month or month and a half.Increasing pain in the left hip and thigh.Follow up with the orthopedic surgeon revealed a broken pin.No tripping, no falls.No pin pointable event to cause the breakage.On (b)(6) 2024 pin was removed and replaced with extra bracing.Pain and swelling still decreasing as of on (b)(6) 2024.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was received in broken condition.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.The device inspection revealed the following: the nail was completely broken in the thinned webs of the proximal drill hole for the lag screw.The 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 of the webs at lateral and had progressed towards medial.The drill hole¿s edges at lateral were washed out and significantly deformed.The intense and kind of deformation did not allow a conclusion if the drill hole had been damaged intra-operative during preparation of the cannulation for the lag screw.However, even wear weakens the material.At medial the inferior edge of the proximal drill hole showed tremendous material deformation in the bearing points (caused by the lag screw).The post-operative load had even caused secondary cracks in the material.In the case presented a 75-year-old male patient had been treated with above nail because of a left femur fracture on september 04, 2023.On january 05, 2024, the item was removed due to breakage and replaced by a nail supported by a plate.Medical records with medication, op-reports and follow-ups were provided.All documents were forwarded to a hcp for review.His comments (in excerpts): "this event is similar to many earlier ones.A subtrochanteric fracture.These are very unstable fractures and need a proper/ ideal reduction and sufficient stability to minimize continuous movement of the fractures parts.From a biomechanical perspective this fracture was not treated ideally.The reduction of the fracture is not ideal, the placement of the lagscrew is very low in the femoral head, and the tad (tip-apex distance is far from ideal.All these factors may contribute to early failure of the implant.These factors contributed to continuous movement in the fracture parts and with that in the nail/ lag screw interface, which could lead to early fatigue breakage.Which in this case also happened.This is what would have happened in most patients irrespective of any patient factors." based on investigation, the root cause of the reported event is muti-factorial: the location of the fracture, the choice of the implant given that location, the technical aspects of the surgical procedure.Furthermore, patient activity levels post-op may have contributed to an inadequate load distribution, and therefore the breakage of the implant.Based on investigation, the root cause was attributed to a user related issue; potentially contributed by high load by the patient.With available information a product deficiency was not verified.
Event or Problem Description
As reported: "broke my thigh bone (b)(6) 2023 and pin was inserted.Functioned normally for a month or month and a half.Increasing pain in the left hip and thigh.Follow up with the orthopedic surgeon revealed a broken pin.No tripping, no falls.No pinpointable event to cause the breakage.(b)(6) 2024 pin was removed and replaced with extra bracing.Pain and swelling still decreasing as of (b)(6) 2024".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X420MM X 130°
• 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: 18862172
• Report Number: 0009610622-2024-00094
• Device Sequence Number: 3314113
• Product Code: HSB
• UDI-Device Identifier: 07613252274483
• UDI-Public: 07613252274483
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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 Catalogue Number: 35301420S
• Device Lot Number: K05054E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 84 KG