MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X260MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0260S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/02/2020
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
It was reported, on (b)(6) 2019 the patient underwent operation with gamma 3 nail.A few months after the surgery, the patient¿s pain continued.On (b)(6) 2020 at the time of the hospital visit, breakage of the gamma nail was confirmed.The revision bha procedure was performed with other company product.
Event or Problem Description
It was reported, on (b)(6) 2019 the patient underwent operation with gamma 3 nail.A few months after the surgery, the patient¿s pain continued.On 26 feb 2020 at the time of the hospital visit, breakage of the gamma nail was confirmed.The revision bha procedure was performed with other company product.
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, left gamma3® ø10x260mm x 125° was alleged of implant - breakage post-operative could be confirmed, since the provided x-ray image confirmed the nail breakage.Based on investigation the nail breakage is not linked to a deficiency of the device but is rather considered patient related contributed by an intra-operative damage of the nail by a deviated lag screw step drill, which most likely had created the starting point of the fracture (notching effect).Failures in material or manufacturing of the affected nail returned were not found.Dimensional examination revealed no deviations in the relevant undamaged areas of the device in question.The affected item reported was documented as faultless prior to distribution.Thus, we exclude deviations in material and manufacturing.The received nail is completely broken in the webs of the proximal lag screw thru hole.According to the damage and the evidences of the breakage surfaces, the nail broke in a fatigue fracture due to axial overload.Significant drill marks are found at the lateral entrance of the proximal thru hole for the lag screw at the anterior web; they progress through the bore towards medial.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) at the lateral edge of the anterior web.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.According to further details provided the broken gamma3 long nail was revised by a bha procedure with other company product which could be a hint to insufficient bone healing after an implantation period of approx.5 months and in addition that a sufficient bone healing is no longer be expected.As we received only a one-plane image and thus, medical statement deemed not necessary in this case.According to further details provided ¿no no further information will be released by the hospital or surgeon¿.Axial overload had led to continuous stresses and a significant weakening of the nail in the area of the lag screw thru hole, followed by the fatigue fracture after implantation duration of approx.5 months.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.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X260MM 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; DE D-24232
• MDR Report Key: 9890722
• Report Number: 0009610622-2020-00126
• Device Sequence Number: 3041017
• Product Code: HSB
• UDI-Device Identifier: 04546540375698
• UDI-Public: 04546540375698
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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: 11/30/2022
• Device Model Number: 3525-0260S
• Device Catalogue Number: 35250260S
• Device Lot Number: K0C2D90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 06/11/2020
• 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