MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31252170S

Device Problem Device Damaged by Another Device (2915)

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

Event Date 10/27/2023

Event Type  Injury  

Event Description

As reported: "intraoperative interference between the step drill and the nail was observed.The nail was replaced and the procedure was completed without problems.".

Manufacturer Narrative

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

Manufacturer Narrative

The reported event could not be confirmed, since the device was returned, but found to be functional.The received nail was visually inspected and found to be in good condition overall.A functional inspection was conducted with the returned nail, target device, speed lock sleeve, and nail holding screw, with a sample drill and sample drill sleeve, in which we can see if the speed lock is locked at the proper angle, which matches with the nail there is no misdrilling.If there is a mismatch between the angle of the nail and the angle locked at the target device and speed lock, there will be a mismatch.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 root cause can be attributed to user related as a functional inspection was performed with a returned nail that proves that the nail is perfectly functional.If any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "intraoperative interference between the step drill and the nail was observed.The nail was replaced and the procedure was completed without problems.".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 125°
• 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: 18182537
• MDR Text Key: 328678594
• Report Number: 0009610622-2023-00428
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375094
• UDI-Public: 04546540375094
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 31252170S
• Device Lot Number: K05F94F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2022
• 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