MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31301180S

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported by rep: patient: (b)(6) presenting with right intertrochanteric fracture being treated with a gamma 3 short nail.Incident report procedure began and followed operative technique protocol, entry made using curved awl, inserted a k-wire through the cannulation & prepared proximal femur with reamer.Nail was selected, connected to targeting jig and calibration check was confirmed using the step drill.Nail was inserted to desired depth and k-wire inserted into femur head as-per operative technique.Measured 90mm, consultant informed this would be to base of k-wire threads.Decision was made to increase to 95mm.Femur was drilled to prepare for lag screw and lag screw inserted to desired depth.However, issue arose with set screw.Set screw was connected to set screwdriver, closed loop clip connected to jig and then set screw inserted.Consultant was instructed to ¿wiggle¿ the screwdriver before engaging threads, seeking for the notable drop to the start of the threads.Set screw was then advanced by turning the screwdriver clockwise, after a few turns it became apparent significant resistance was being encountered and an audible squeaking was heard.I instructed the consultant to check for rotational stability by attempting to rotate the lag screwdriver.The lag screwdriver was still freely rotating confirming the set screw wasn¿t correctly seated.Consultant continued to advanced the screwdriver, audible feedback became louder, i cautioned against the possibility of the set screw being cross threaded.Consultant initially wanted to progress without set screw and was informed it is a mandatory step for gamma procedures.Further attempts to advance (without any attempt to back out to check threads) until the screwdriver was broken.Resolution on day: all equipment and implants were removed from the patient, two new gamma 3 sets were opened and replacements for nail, lag screw (now 90mm) and k-wire opened.With the new nail inserted procedure was completed without incident.However, i made the strong recommendation to wiggle the set screwdriver into the jig and only turn with gentle pressure.Should excessive force be encountered do not progress.Rotational stability was confirmed with the lag screw t handle.Distal locking was then completed.

Event Description

As reported by rep: patient: (b)(6) female presenting with right intertrochanteric fracture being treated with a gamma 3 short nail.Incident report: procedure began and followed operative technique protocol, entry made using curved awl, inserted a k-wire through the cannulation & prepared proximal femur with reamer.Nail was selected, connected to targeting jig and calibration check was confirmed using the step drill.Nail was inserted to desired depth and k-wire inserted into femur head as-per operative technique.Measured 90mm, consultant informed this would be to base of k-wire threads.Decision was made to increase to 95mm.Femur was drilled to prepare for lag screw and lag screw inserted to desired depth.However, issue arose with set screw.Set screw was connected to set screwdriver, closed loop clip connected to jig and then set screw inserted.Consultant was instructed to ¿wiggle¿ the screwdriver before engaging threads, seeking for the notable drop to the start of the threads.Set screw was then advanced by turning the screwdriver clockwise, after a few turns it became apparent significant resistance was being encountered and an audible squeaking was heard.I instructed the consultant to check for rotational stability by attempting to rotate the lag screwdriver.The lag screwdriver was still freely rotating confirming the set screw wasn¿t correctly seated.Consultant continued to advanced the screwdriver, audible feedback became louder, i cautioned against the possibility of the set screw being cross threaded.Consultant initially wanted to progress without set screw and was informed it is a mandatory step for gamma procedures.Further attempts to advance (without any attempt to back out to check threads) until the screwdriver was broken.Resolution on day: all equipment and implants were removed from the patient, two new gamma 3 sets were opened and replacements for nail, lag screw (now 90mm) and k-wire opened.With the new nail inserted procedure was completed without incident.However, i made the strong recommendation to wiggle the set screwdriver into the jig and only turn with gentle pressure.Should excessive force be encountered do not progress.Rotational stability was confirmed with the lag screw t handle.Distal locking was then completed.

Manufacturer Narrative

The reported event could be confirmed since the device was returned and matches alleged failure.From the visual inspection of the received nail, we can see that the implant was overall in good condition, but we can see that the set screw was stuck in the received nail.Functional inspection was conducted to remove the set screw from the nail we can see that the threads are completely flatted and from the thread metal chips have started to fragment out which indicates that the set screw was not properly aligned and forced into the threads leading to cross threads.After the removal, we can also see that the human tissue and blood residual was available on the screw.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 above investigation, the jamming of the set screw inside the nail is deemed to be a user-related issue as we have clear signs of cross-threading which was also stated in the event description.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°
• Type of Device: 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: 18469671
• MDR Text Key: 332377621
• Report Number: 0009610622-2024-00015
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: 04546540375124
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 31301180S
• Device Lot Number: K170C8D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR
• Patient Sex: Female