MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X300MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0300S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "on (b)(6) 2021, gamma 3 long nail was implanted for femoral trochanteric fracture due to bone tumor.In (b)(6) 2022, without a fall, the patient felt pain during daily activities and the x-rays revealed nail fracture.During revision, the broken nail was removed and gmrs was used.".
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded by the hospital.
Additional Manufacturer Narrative
The reported event that could not be confirmed, since the device was not returned and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned.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.More information such as patient¿s medical records and the device itself must be available in order to determine the exact root cause of the issue.As a secondary observation it was observed that the nail had expired in the month of april 2020 as per the manufacturing records, however the nail was implanted in november 2021.This is deemed to be an off label use.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "on (b)(6) 2021, gamma 3 long nail was implanted for femoral trochanteric fracture due to bone tumor.In february 2022, without a fall, the patient felt pain during daily activities and the x-rays revealed nail fracture.During revision, the broken nail was removed and gmrs was used.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X300MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13770790
• Report Number: 0009610622-2022-00095
• Device Sequence Number: 11753914
• Product Code: HSB
• UDI-Device Identifier: 04546540375322
• UDI-Public: 04546540375322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 04/30/2020
• Device Model Number: 3425-0300S
• Device Catalogue Number: 34250300S
• Device Lot Number: K028E97
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: 68 YR
• Patient Sex: Female