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

Model Number 3125-1180S

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The pharmacist reported to the (b)(6) the following event : " during a surgery related to the implantation of a gamma 3 nail, it was impossible to retrieve the target device.The medical staff had to re-start the surgery with another device.The unlocking was finally made by a nurse at the sterilization.The extracted nail and the target device have been placed in quarantined ".

Manufacturer Narrative

This report can be disregarded, as it is a duplicate of report # 0009610622-2019-00999.

Event Description

The pharmacist reported to the ansm the following event : " during a surgery related to the implantation of a gamma 3 nail, it was impossible to retrieve the target device.The medical staff had to re-start the surgery with another device.The unlocking was finally made by a nurse at the sterilization.The extracted nail and the target device have been placed in quarantined ".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9616605
• MDR Text Key: 185670236
• Report Number: 0009610622-2020-00029
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3125-1180S
• Device Catalogue Number: 31251180S
• Device Lot Number: K09980E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1