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

Catalog Number 13200111

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Miss drilling occurred often during distal locking of the 200 gamma nail.According to the surgeon, all the steps were performed as indicated in the surgical guide.

Manufacturer Narrative

The reported event could not be confirmed, since the product was returned for evaluation but doesn¿t match the reported failure as the reported event could not be reproduced and the device was found fully functional.The device inspection revealed the following: a functional inspection was performed by assembling targeting device with a sample nail & sample drill, it was found that the drill could pass easily through the distal hole (oblong) without any contact with the nail.The device was working fine.Therefore, the reported event could not be confirmed or reproduced.Based on investigation, the root cause was attributed to a user related issue.Evaluation revealed that there is no issue with the reported device and that it has more to do with user handling error.Based on complaint history some of the possible user handling errors of this failure are: improper positioning of nail, target sleeve adjustment is incorrect, target sleeve is not locked, sleeves not fixed or not introduced far enough, load on instruments by soft tissue (incision not precise) etc.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The ifu clearly instructs that: ¿during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure¿.If any further information is provided, the complaint report will be updated.

Event Description

Missdrilling occurred often during distal locking of the 200 gamma nail.According to the surgeon, all the steps were performed as indicated in the surgical guide.

• 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
• MDR Report Key: 8739915
• MDR Text Key: 149632499
• Report Number: 0009610622-2019-00523
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• 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: KME908744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1