MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL 170MM GAMMA4 Ø12X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81252170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised from a trochanteric nail gamma4 nail to a total hip due to the rotation of lag screw not being maintained.
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.
Event or Problem Description
It was reported that the patient was revised from a trochanteric nail gamma4 nail to a total hip due to the rotation of lag screw not being maintained.
Additional Manufacturer Narrative
The reported event of a revised nail to tha could not be confirmed but an unintended lag screw movement could be confirmed based on the image provided, only.A physical device inspection was not possible since the affected device was not returned and thus, limited to details available.X-ray image [situ prior to revision surgery] presents a lag screw medialization [migration].As per further details provided under event description ¿the lag screw is catalog number is 3066-0095 with a lot number of k0e04e6.¿ dhr review revealed that in the current case a u-blade set, ti gamma3 ø10.5x95mm was used for the treatment of above referenced trochanteric nail 170mm gamma4 ø12x170mm x 125°.The gamma4 ifu clearly instructs as following: do not use components of the gamma4 system together with components from another stryker system or any other manufacturer unless specified otherwise in the labeling of the gamma4 system and thus, the case is clear user related and has to be classified as user-customer-deviation from surgical technique.Finally, the gamma3 ifu also points out that implants which consist of several components must only be used in the prescribed combination.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: TROCHANTERIC NAIL 170MM GAMMA4 Ø12X170MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 20091631
• Report Number: 0009610622-2024-00819
• Device Sequence Number: 7736714
• Product Code: HSB
• UDI-Device Identifier: 07613327479348
• UDI-Public: 07613327479348
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• 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): 11/19/2024

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 Catalogue Number: 81252170S
• Device Lot Number: K18D18E
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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: Female