MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3120-1180S

Device Problem Mechanical Jam (2983)

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

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned. If additional information becomes available, it will be provided in a supplemental report.

Event Description

Customer reported the following issue regarding a gamma nail ref. 3120-1180s, lot k05cc65 and the ancillary material necessary for its installation (nail, target device, bolt): "during an operation on (b)(6) 2021, the material was fitted without any problems until the nail had to be removed from the target device to complete the operation: it was impossible to unscrew. The consequences were a doubling of the operation time due to the need to remove everything to start the whole operation again, and the need to use another ancillary and another nail less adapted to the patient".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12849558
• MDR Text Key: 282918947
• Report Number: 0009610622-2021-00795
• Device Sequence Number: 1
• Product Code: HSB
• 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: 03/07/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3120-1180S
• Device Catalogue Number: 31201180S
• Device Lot Number: K05CC65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial