MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	32250320S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: device disposition is unknown.
Event or Problem Description
The following report was received from (b)(6): during the removal of a gamma nail long, used to reduce a multifragmented right femur fracture, distally and proximally blocked, the surgeon has noticed visible signs of rubbing of the cephalic screw on the nail in an abnormal location: out of the channel that normally houses the cephalic screw.The system is normally used percutaneously, so without a direct view of the operator but only via rx.The system is collimated by cannulas that allow this procedure.So customer reports that the incident is inexplicable except with an alleged defect in the instruments.Adverse event: asymmetry, lack of bone calcification.
Additional Manufacturer Narrative
The reported event could not be confirmed.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.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.
Event or Problem Description
The following report was received from the italy competent authority org.(moh): during the removal of a gamma nail long, used to reduce a multifragmented right femur fracture, distally and proximally blocked, the surgeon has noticed visible signs of rubbing of the cephalic screw on the nail in an abnormal location: out of the channel that normally houses the cephalic screw.The system is normally used percutaneously, so without a direct view of the operator but only via rx.The system is collimated by cannulas that allow this procedure.So customer reports that the incident is inexplicable except with an alleged defect in the instruments.Adverse event: asymmetry, lack of bone calcification.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM 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
• MDR Report Key: 8596807
• Report Number: 0009610622-2019-00241
• Device Sequence Number: 2281116
• Product Code: HSB
• UDI-Device Identifier: 07613153312734
• UDI-Public: 07613153312734
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 32250320S
• Device Lot Number: K0DFBE0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 08/17/2019
• 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
• Patient Age: 54 YR