MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X345 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18220934S

Device Problems Activation, Positioning or SeparationProblem (2906); Material Deformation (2976)

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

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition unknown.

Event Description

It was reported that, during a tibial nail procedure, when it came time to attach the nail to the holding bolt, the threads inside the nail would not engage with the holding bolt. Multiple attempts with no success. A second nail was opened and the nail successfully engaged with the holding bolt. Two minute surgical delay reported. No adverse consequences were reported.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø9X345 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8483110
• MDR Text Key: 141183041
• Report Number: 0009610622-2019-00143
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003018
• 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: 06/07/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 18220934S
• Device Lot Number: K0E3001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial