MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1400S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the gamma nail which was implanted in (b)(6) 2021 has broken post implantation, requiring revision surgery.
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Please note correction to d6a.The reported event could be confirmed, since the nail is broken as complained.The device inspection revealed the following: the visual inspection has shown that the nail is broken apart at the lag screw hole.Under the microscope the typical characteristics of a fatigue fracture could be identified on both fracture faces of the head element.The origin of the crack was at the lower corners and there is a fatigue zone with progression lines.The instantaneous zone where the nail finally broke apart is visible too.On one side of the bore are slight stress marks visible, most likely caused during reaming.On top of the bore is an impression mark visible, caused by high loads between the nail and the lag screw.At the crack initiation point is also a deformation visible, but afterwards it cannot be defined if the damage was caused during insertion or in situ by rubbing on the lag screw after the breakage.The relevant dimensions were as far as possible checked and no deviation from the specification could be detected.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.The complaint was forwarded to medical affairs for a medical opinion with following feedback: what we can deduce from the provided x-rays is that there are some patient related factors: weight, an unfavorable, very long fracture pattern with complete instability due to bone loss in the subtrochanteric area, signs of vascular calcinosis indicating poor metabolism.From the surgical side no additional surgical measurements like cerclage or further fragment reduction were taken.Both factors have contributed to the failure, the main cause, however, is the fracture pattern.Based on investigation, the root cause was attributed to a patient related issue.Different patient related factors did result in an overload at the nail/lag screw intersection followed by fatigue failure of the nail in this area.If more information is provided, the case will be reassessed.
Event or Problem Description
The customer reported that the gamma nail which was implanted in (b)(6) 2021 has broken post implantation, requiring revision surgery.Additional information received - 10/19/2021: the event is related to a fall.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X400MM 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12755552
• Report Number: 0009610622-2021-00772
• Device Sequence Number: 3133649
• Product Code: HSB
• UDI-Device Identifier: 07613252274315
• UDI-Public: 07613252274315
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 08/31/2025
• Device Model Number: 3525-1400S
• Device Catalogue Number: 35251400S
• Device Lot Number: K047E6B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 11/06/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 85 KG