MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1320-0111

Device Problem Failure to Align (2522)

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

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "the surgeon had inserted the drill tip k-wire and used the cannulated lag screw drill to prepare for the lag screw.The surgeon noticed an increase in resistance but managed to drill the entire track.After drilling the lag screw was attached to the lag screw screwdriver trough the proximal targeting device.The lag screw went in for a bit after which it would not get any deeper.The surgeon checked for: good attachment of the nail holding screw, right ccd angle of the targeting device and if the k-wire was still straight.The surgeon tried again with no success.After this attempt the surgeon removed the nail and lag screw and tried to insert the lag screw trough the targeting device outside the patient, but again the lag screw was running against the nail and could not progress.A new nail and lag screw were used after which the surgery progressed without any further problems.The nail and lag screw were cleaned and were brought to the mec truck which was on their property.The procedure was done again with the use of the proximal aiming device that is available in the mec truck.With the first try, the same issue was encountered.Later on the day it was shown again to someone else, and the issues were not encountered.".

• Brand Name: TARGET DEVICE GAMMA3
• 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: 11121326
• MDR Text Key: 227978381
• Report Number: 0009610622-2021-00069
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123401
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1320-0111
• Device Catalogue Number: 13200111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• 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
• Patient Age: 80 YR
• Patient Weight: 60