MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Implant Pain (4561)
Date of Event	05/04/2022
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: "gamma nail is broken.The patient required revision surgery." additionally the patient had sudden exertional pain on the morning of (b)(6) 2022.The patient was revised to a cementless stem and bipolar cup.
Additional Manufacturer Narrative
The reported event could be confirmed, since physical inspection revealed a broken nail.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 evidence of the breakage surfaces, the nail broke in a fatigue fracture due to axial overload.The anterior web broke first, starting with an incipient crack at lateral.This web had been damaged intra-operatively by the step drill.The lateral edge was significantly weakened by a chamfer where the incipient crack was identified.The breakage of the posterior web followed with delay, progressed towards medial and broke in a residual fracture in the medial edge.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 cementless stem and bipolar cup which can be considered as a hint to insufficient bone healing after an implantation period of approx.24.5 weeks and in addition that a sufficient bone healing is no longer be expected.We received a sequence of x-ray images which were forwarded to our hcp for a medical statement.His comments [excerpts]: ¿¿from a clinical point of view: insufficient rigid fixation of a challenging fracture in an 89-year-old where fracture healing did not occur timely to prevent breakage of the device.The fracture hasn¿t healed yet.And most likely will not heal with a broken device in place¿¿ 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.24.5 weeks.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "gamma nail is broken.The patient required revision surgery." additionally the patient had sudden exertional pain on the morning of (b)(6) 2022.The patient was revised to a cementless stem and bipolar cup.
Additional Manufacturer Narrative
Please note that the results and conclusion were updated.
Event or Problem Description
As reported: "gamma nail is broken.The patient required revision surgery." additionally the patient had sudden exertional pain on the morning of (b)(6) 2022.The patient was revised to a cementless stem and bipolar cup.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM 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
• 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: 14574968
• Report Number: 0009610622-2022-00213
• Device Sequence Number: 17686567
• Product Code: HSB
• UDI-Device Identifier: 07613252273837
• UDI-Public: 07613252273837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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: 04/30/2026
• Device Model Number: 3425-1360S
• Device Catalogue Number: 34251360S
• Device Lot Number: K023705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 09/05/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/29/2022; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 80 KG