MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X420MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3125-1180S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Necrosis (1971); Osteomyelitis (4533)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device remains implanted in patient.
Event or Problem Description
As reported: "i take care of a patient after osteosynthesis of the right femur.The operation was carried out in (b)(6) 2019.The patient came to our department for femoral head necrosis with osteomyelitis and soft tissue abscess of the thigh.We need to extract the implants.This is a stryker 3 gamma nail system.The operation is scheduled for (b)(6) 2022.".
Event or Problem Description
As reported: "i take care of a patient after osteosynthesis of the right femur.The operation was carried out in (b)(6) 2019.The patient came to our department for femoral head necrosis with osteomyelitis and soft tissue abscess of the thigh.We need to extract the implants.This is a stryker 3 gamma nail system.The operation is scheduled for (b)(6) 2022.".
Additional Manufacturer Narrative
The received x-ray was reviewed and the reported necrosis can be confirmed.Only based on this picture it is not possible to determine if the necrosis is in relation with the implants, especially as the devices were implanted for more than 3 years.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X420MM 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: 16061209
• Report Number: 0009610622-2022-00605
• Device Sequence Number: 12445784
• Product Code: HSB
• UDI-Device Identifier: 07613252273868
• UDI-Public: 07613252273868
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: 09/30/2023
• Device Model Number: 3125-1180S
• Device Catalogue Number: 34251420S
• Device Lot Number: K05BE15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2018
• 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 Sex: Unknown