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

Catalog Number	35251360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
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
It was reported that due to a nail breakage a revision surgery will be performed.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that due to a nail breakage a revision surgery will be performed.
Event or Problem Description
It was reported that due to a nail breakage a revision surgery will be performed.
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.Failures in material or manufacturing of the affected nail returned were not found.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 posterior web broke first.The breakage of the anterior 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.As per event description ¿revision will be performed¿ and current reported long nail kit r1.5, ti, left gamma3® ø11x360mm x 125° will be revised by an unknown implant, which could also be seen as a hint for insufficient bone healing.Thus, it could not be excluded that the implant had to absorb / transfer the whole loading because it was not relieved by increasing bone healing.It could not be determined if pre-aging had contributed to the event.Due to missing x-rays it could not be determined whether reduction had been performed according to anatomical requirements and furthermore, if the implant positioning was according to anatomical requirements as well.Furthermore, as no further information such as x-rays, medical records or surgery reports was provided, a real medical statement was impossible.Finally, it could not be determined what range of weight bearing had been advised by the surgeon for the post-operative period.It could also not be determined if the patient had been compliant to the instructions.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.Axial overload had led to continuous stresses and a significant weakening of the nail around the lag screw thru hole, followed by the fatigue fracture after an unknown implantation duration.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.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125°
• 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: 17844160
• Report Number: 0009610622-2023-00338
• Device Sequence Number: 17935507
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• UDI-Public: 07613252274285
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2024

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: 35251360S
• Device Lot Number: K053735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 01/16/2024
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/29/2023; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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 Sex: Unknown