MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported a patient with normal weight showed fracture of the gamma nail four weeks after implantation.In the further course, the locking screw also broke, even if the screw in this case is to be considered too short.The patient required a revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail is broken apart as complained.The device inspection revealed the following: the inspection has shown that the nail broke apart at the lag screw hole.The typical characteristics of a fatigue fracture could by identified under the microscope.On one side of the bore are stress marks visible, most likely caused during reaming.On top of the bore are impression marks visible, caused by high loads between the nail and the lag screw.The relevant dimensions were verified as far as possible during the investigation 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 nail was returned for evaluation and no product related issue could be detected.The provided information is contradicting itself, the complaint description states that the nail broke 4 weeks after insertion, but this breakage cannot be confirmed on the received x-rays.On the other side does the operation report state that the breakage occurred 3-4 weeks prior to the revision, which was performed 6 months after the implantation.Requests for clarification to the customer were made but no additional information was made available.Therefore the root cause of the breakage cannot be defined.The evaluation of the nail has shown that fatigue did lead to the breakage of the device.In this relation following statement from the instructions for use (non-active implant) can be mentioned: [these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.] [original statement].If updated information is provided, the case will be reassessed.
Event or Problem Description
It was reported a patient with normal weight showed fracture of the gamma nail four weeks after implantation.In the further course, the locking screw also broke, even if the screw in this case is to be considered too short.The patient required a revision surgery.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM 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: 12676146
• Report Number: 0009610622-2021-00764
• Device Sequence Number: 14585423
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 07613153313533
• 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: 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): 02/14/2022

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: 07/31/2023
• Device Model Number: 3325-0380S
• Device Catalogue Number: 33250380S
• Device Lot Number: K0A73C0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2018
• 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: 82 YR
• Patient Sex: Female