MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251340S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	05/23/2023
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.H3 other text : device discarded.
Event or Problem Description
As reported: "the implantation took place on (b)(6) 2022.Since on (b)(6) 2023, there was increasing pain, then in x-ray on (b)(6) 2023 there was evidence of implant fracture." this resulted in a revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed from the available radiographs.From the available radiographs, a formal medical opinion was sought:- the fracture is a very unstable multi-fragmentary sub/ per trochanteric fracture.Available radiographs after surgery show only the pelvic view.Unfortunately, there is no lateral view.The lateral view could help further judge the reduction of the proximal part of the fracture.Besides the reduction, the aftercare for this type of fracture is extremely important but with the limited available information, it is hard to draw a conclusion as we are not aware, of whether the patient¿s weight-bearing was reduced or full from the start.From the last x-ray it is clear that there is a non-union after 7 months, there is some callus formation, but clearly not sufficient.There must have been continuous movement in the fracture to cause the nail to break in a fatigued manner at the lag screw interface.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.Based on the investigation, the root cause attributed can most likely be user-related.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the implantation took place on (b)(6) 2022.Since (b)(6) 2023 there was increasing pain, then in x-ray on (b)(6) 2023 there was evidence of implant fracture." this resulted in a revision surgery.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X340MM 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: 17378158
• Report Number: 0009610622-2023-00264
• Device Sequence Number: 6182769
• Product Code: HSB
• UDI-Device Identifier: 07613252273820
• UDI-Public: 07613252273820
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 34251340S
• Device Lot Number: K069963
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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