MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3125-0170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	12/15/2022
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.Should additional information become available, it will be provided in a supplemental report.Device disposition.
Event or Problem Description
As reported: "a patient who underwent surgery with a gamma3 u-lag screw on (b)(6) 2018, fell while transferring from a portable toilet at home on (b)(6) 2022.Subsequently, it was discovered that she had a femoral neck fracture on left side, so on (b)(6) 2022, she underwent surgery to remove gamma 3 and replaced it with a bipolar.".
Event or Problem Description
As reported: "a patient who underwent surgery with a gamma3 u-lag screw on (b)(6) 2018, fell while transferring from a portable toilet at home on (b)(6) 2022.Subsequently, it was discovered that she had a femoral neck fracture on left side, so on (b)(6) 2022, she underwent surgery to remove gamma 3 and replaced it with a bipolar.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Based on details available an exact root cause could not be confirmed but it could not be excluded that the reported event is rather related to the patient [unusual changes in the implantation area e.G.Falls or accidents], which is confirmed by event description ¿¿fell while transferring from a portable toilet at home on (b)(6), 2022.¿.Furthermore, as per ifu ¿the surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.¿ after initial nail treatment on (b)(6) 2018 the patient fell in (b)(6) 2022 and ¿subsequently, it was discovered that she had a femoral neck fracture on left side, so on (b)(6), 2022, she underwent surgery to remove gamma 3 and replace it with a bipolar¿.Finally, as per further details available non-broken nail was confirmed and ¿no defects in product¿.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.With details provided no deviation for the nail in question was verified.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM 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: 16133828
• Report Number: 0009610622-2023-00007
• Device Sequence Number: 16940936
• Product Code: HSB
• UDI-Device Identifier: 04546540375063
• UDI-Public: 04546540375063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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: 01/31/2023
• Device Model Number: 3125-0170S
• Device Catalogue Number: 31250170S
• Device Lot Number: K018C95
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2018
• 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