MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3125-1180S

Device Problem Positioning Failure (1158)

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

Event Date 05/06/2023

Event Type  Injury  

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 Description

As reported: "after placement of the nail and cephalic screw, impossible placement of the locking screw with an audible noise as soon as the screw was put in contact without starting to screw.The team was forced to remove all the material and re-install another nail.When the nail was tested outside the patient, the locking screw was still not inserted.Additionally, there was a delay of 20 to 30 minutes.".

Manufacturer Narrative

Please note correction to d3 (manufacturer entity) and d4 (lot #).The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

As reported: "after placement of the nail and cephalic screw, impossible placement of the locking screw with an audible noise as soon as the screw was put in contact without starting to screw.The team was forced to remove all the material and re-install another nail.When the nail was tested outside the patient, the locking screw was still not inserted.Additionally, there was a delay of 20 to 30 minutes.".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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: 17062148
• MDR Text Key: 316573640
• Report Number: 0009610622-2023-00191
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3125-1180S
• Device Catalogue Number: 31251180S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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