MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X360MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-3360S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "on the (b)(6) 2020 the patient falls and gets a long gamma3 nail due to a subtrochanteric fracture.The patient comes to a xray control on (b)(6) because of pain.The patient did not heal, and in retrospect the surgeon can see on the x-rays, that the nail had given in on pt control (b)(6) 2020.The patient's pain got worse and the nail gave in.There were lack of healing.On the patient got a reoperation with exchange of nail, and grafting.Outcome is still uncertain.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.The appearance of the breakage surface of the posterior web suggests that the nail breakage had its origin in this area.Severe material erosion is evident all around both the webs along with heavy explantation marks that were caused during the extraction of the nail.The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest/ waves on the posterior web.Starting from that region with an incipient crack at the lateral edge (notching effect caused due to very slight mis-drilling), the breakage progressed through the cross section.As a result of which the anterior web broke in a much quicker way with increased loading as result of nonunion.Signs of overloading are also evident by the bearing marks visible on the medial edge of the nail.A dimensional inspection of all the undamaged area revealed the nail to be within the specifications.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.A clinical statement was requested for the evaluation of the provided medical data.The following statements were provided: ¿the surgeon has done well.The reposition seems to be good.The fracture is highly complicated, though: a reversed oblique fracture with a large and long medial fragment lasting about 10cm below the main subtrochanteric fracture region.Although the good reposition was supported with three cerclages the lesser trochanter fragment is missing, as it is massively dislocated proximally.The fragment is pretty large as well with a distal spike and spanning approx.4-5 cm.Therefore, the medial support is missing and the load is taken over almost completely by the nail.The subtrochanteric region is -due to impaired metabolism in the bone- known to be associated with frequent non-union.Independent from this the hip joint is pretty altered with a progressed arthrosis.Other factors may have contributed to the failure, but the most relevant factor is the unfortunate fracture pattern and the missing reposition of the lesser trochanter fragment.¿ based on the above investigation, it is evident that the nail broke due to a combination of factors including a non-union, a complex fracture pattern, and slight contribution due to mis-drilling but predominantly the root cause of the failure can be attributed to a complex fracture pattern and the associated non-union which all are patient related factors.As a result of which there was an increased loading on the nail and ultimately it broke.General aspect: bearing points are typical results of the interaction of the single products under load.Areas with signs of friction / seizing [bearing points of lag screw] are visible at the distal medial edge.The counterparts were found on the lag screw in the areas with corresponding friction signs and worn edges.The appearance identified a high axial load application to the implants.The affected nail 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.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "on the (b)(6) 2020 the patient falls and gets a long gamma3 nail due to a subtrochanteric fracture.The patient comes to a xray control on the (b)(6) because of pain.The patient did not heal, and in retrospect the surgeon can see on the x-rays, that the nail had given in on pt control (b)(6) 2020.The patient's pain got worse and the nail gave in.There were lack of healing.On the (b)(6) the patient got a reoperation with exchange of nail, and grafting.Outcome is still uncertain.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X360MM X 125
• 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
• MDR Report Key: 10329690
• Report Number: 0009610622-2020-00371
• Device Sequence Number: 2525935
• Product Code: HSB
• UDI-Device Identifier: 04546540406668
• UDI-Public: 04546540406668
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 06/30/2024
• Device Model Number: 3425-3360S
• Device Catalogue Number: 34253360S
• Device Lot Number: K07FB17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 69