MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 34250340S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

During gamma3 surgery, the nail tip perforated anterior cortical bone.Since it was found after lag screw was completely implanted, the surgeon did not attempt re-insertion the nail.The surgery was finished after implantation of a locking screw.In the surgeon's opinion, the patient's cortical bone was very thin.

Manufacturer Narrative

The reported event that long nail kit r1.5, ti, right gamma3® ø10x340mm x 125° was alleged of 'adverse impact on patient / patient related / iatrogenic issue' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.The failure was caused by implanting the device in a bone stock compromised by disease.Indeed, the reported event is an iatrogenic fracture, which is not the device's fault.As a reminder, the ifu states: " ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.For your information, avail yourself of the training courses and publications offered (e.G.Operative techniques)," as well as: " bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/ or fixation of the devices." 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

During gamma3 surgery, the nail tip perforated anterior cortical bone.Since it was found after lag screw was completely implanted, the surgeon did not attempt re-insertion the nail.The surgery was finished after implantation of a locking screw.In the surgeon's opinion, the patient's cortical bone was very thin.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125°
• 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: 7555182
• MDR Text Key: 109617136
• Report Number: 0009610622-2018-00228
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 34250340S
• Device Lot Number: K0A3B1A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR