MAUDE Adverse Event Report: STRYKER GMBH G4 LONG NAIL RIGHT D11XL360MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84251360S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Cyst(s) (1800); Perforation (2001)
Date of Event	12/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "gamma4 nail to fix an intertroch fx.4-6 week post op xrays looked normal, as expected.Pt then presented to ed 12/9, -xrays showed lag screw completely disengaged and medialized.Patient needed revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed on a provided x-ray copy where the lag screw had completely disengaged from the nail and had medialized.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 the case presented an (b)(6) -year-old female patient had been treated with above gamma4 nail.Initial healing course was without events.After approx.2 months the patient presented with completely disengaged and medialized lag screw.The device inspection revealed the following: the set screw could easily be moved back and forth with a set screwdriver.Both tips of the set screw were slightly plastically deformed at lateral and medial.In 1 tip a clear dent was visible.The form of a dent in the set screw was matching the form of the dents in the flute¿s edge.The set screw inside the nail could easily be screwed.Placing the set screw in the sliding flute and unlocking the set screw for less than ¼ turn enabled free sliding of the lag screw without rotation, as intended.Function was fully given.We received an undated x-ray copy presenting a lag screw that had left the proximal drill hole in the nail and which had protruded into the acetabulum.Magnification of that image revealed the tips of the set screw were flush with the edges of the nail¿ cannulation meaning they were not engaged in the flute of the lag screw.Imprints on the edge of the lag screw¿s superior sliding flute indicated contact to the tips of the set screw.Unscrewing the set screw less than a ¼ turn (as to op-tech) leads to complete release of the lag screw which in turn can freely medialize.The event was of a purely technical nature; a medical assessment was not necessary.Patient is obese and demented.Patient has a bone cyst in the acetabulum, which likely allowed to lag screw to migrate through it so easily.Based on investigation, the root cause was attributed to a user related issue.The patient¿s condition may have contributed to the event.With available evidence and information a product deficiency was not verified.If essential information is provided, we reserve the right to re-open the case and to re-assess the root cause.
Event or Problem Description
As reported: "gamma4 nail to fix an intertroch fx.4-6 week post op xrays looked normal, as expected.Pt then presented to ed 12/9, -xrays showed lag screw completely disengaged and medialized.Patient needed revision surgery.

• Brand Name: G4 LONG NAIL RIGHT D11XL360MM X 125DEG
• 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: 18426894
• Report Number: 0009610622-2024-00006
• Device Sequence Number: 20769398
• Product Code: HSB
• UDI-Device Identifier: 07613327476224
• UDI-Public: 07613327476224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 84251360S
• Device Lot Number: K15865F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2023
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: 89 YR
• Patient Sex: Female