MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2353-3907

Device Problems Difficult to Insert (1316); Failure to Align (2522)

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

Event Date 08/15/2021

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

The end user reported they had a colinear clamp on laterally and when the targeting wing was attached it did hit that clamp.They also reported that with antegrade nails, some roc have mis-matched the patient and made insertion difficult.No adverse consequences were reported to the patient and no clinically significant delay was reported.

• Brand Name: DISTAL TARGETING DEVICE FEMUR RETROGRADE
• 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: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12470746
• MDR Text Key: 271376462
• Report Number: 0009610622-2021-00688
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327411843
• UDI-Public: 07613327411843
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2353-3907
• Device Catalogue Number: 23533907
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1