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

Catalog Number 13200111

Device Problem Difficult to Advance (2920)

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

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Gamma 3 targeter missed on distal locking for a short nail procedure.Device was not damaged.Description: the patient was very obese, the distal locking hole missed, the drill hit the nail and would not advance smoothly through distal hole.The event was resolved by taking of the targeting device and performing a freehand locking technique in the distal most hole of the nail.

Manufacturer Narrative

The reported event that target device gamma3® was alleged of 'distal misdrilling / problems during drilling' could not be confirmed, since the device was not returned for evaluation and as it was mentioned that the material was not returned as the device was not damaged! no failure of the device as such was caused.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

Gamma 3 targeter missed on distal locking for a short nail procedure.Device was not damaged.Description: the patient was very obese, the distal locking hole missed, the drill hit the nail and would not advance smoothly through distal hole.The event was resolved by taking of the targeting device and performing a freehand locking technique in the distal most hole of the nail.

• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6974308
• MDR Text Key: 90849386
• Report Number: 0009610622-2017-00339
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200111
• Device Lot Number: KME908608 241796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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 Outcome(s): Other