MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, STST GAMMA3 10.5X95MM IMPLANT

Catalog Number 40600095S

Device Problem Positioning Failure (1158)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device is not cleared for sale in the u. S. , but a similar device is commercially available in the u. S. Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The customer reported that: "i would like to ask you about a defective 125° short gamma nail. I wanted to insert a short gamma nail this morning for a pertrochanteric fracture. I encountered a problem with the nail locking screw. The cervicocephalic screw was not locking with the proximal locking screw. I mentioned a problem with the cervicocephalic screw. Changing the cervicocephalic screw did not solve the problem. I had to change the 125° short gamma nail, which solved the problem. When testing the nail outside the patient, i found that the locking mechanism of the cervicocephalic screw did not work. I kept the nail in my office in cannes. ".

• Brand Name: LAG SCREW, STST GAMMA3 10.5X95MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11262765
• MDR Text Key: 230753447
• Report Number: 0009610622-2021-00255
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 40600095S
• Device Lot Number: K0F207E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial