MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1340S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "breakage of the nail.A revision will probably have to be performed.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Additional Manufacturer Narrative
Please note correction to d3 (manufacturer entity) and d9/h3.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Material deformation can be seen on the posterior web of distal end which most likely had created the starting point of the fracture at the lateral which is a result of over lying stresses.On the anterior & posterior web of the proximal side final instantaneous breakage can be seen at medial.The lag screw bearing point on the medial side at the distal end shows deformation which is from the high compressive load.This deformation indicates that the nail was exposed to continuous high load over a longer period of time.The breakage pattern resembles a fatigue breakage of the nail, evident by the shiny surface and appearance of lines of rest running from lateral to medial.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.Based on the above investigation and available information, the exact root cause of the failure cannot be established.However the appearance of the breakage indicates towards application of continuous load and overlying stresses on the breakage point which ultimately led to the breakage of the nail in a fatigue manner.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "breakage of the nail.A revision will probably have to be performed.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X340MM 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: 16820689
• Report Number: 0009610622-2023-00134
• Device Sequence Number: 7014324
• Product Code: HSB
• UDI-Device Identifier: 07613252273820
• UDI-Public: 07613252273820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 09/30/2024
• Device Model Number: 3425-1340S
• Device Catalogue Number: 34251340S
• Device Lot Number: K04114C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2019
• 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: 67 YR
• Patient Sex: Female