MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3425-1380S

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device retained by hospital.

Event Description

The customer reported there was a spontaneous fracture of the implantable medical device.Revision surgery was required to put the nail back in place.

Manufacturer Narrative

Please note correction to d4 lot number.The reported event could be confirmed based on images provided, only.A physical device inspection was not possible since the affected device was not made available for evaluation and thus, inspection was limited to the images available.Based on these images a broken nail was verified.The nail is completely broken in the webs of the proximal drill hole for the lag screw.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 did not indicate any abnormalities.No corrective actions are required at this time.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 Description

The customer reported there was a spontaneous fracture of the implantable medical device.Revision surgery was required to put the nail back in place.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 125°
• Type of Device: 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: 12530129
• MDR Text Key: 273361701
• Report Number: 0009610622-2021-00723
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• UDI-Public: 07613252273844
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 3425-1380S
• Device Catalogue Number: 34251380S
• Device Lot Number: K046377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention