MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 35300380S

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Information (3190)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that patient presented with a trochanteric fracture of left side due to a gunshot wound.Surgeon performed a gamma nail and when surgeon was almost done, the targeting arm would not unscrew.Surgeon had to remove hardware and install a new arm which delayed surgery at least 1 hour as a result.Sales rep clarified that the nail, targeting arm and nail holding screw are stuck together.No issues for locking screw were reported "though they did remove and discard it.When they put new nail in, the length of the screw was no longer correct.".

Manufacturer Narrative

Evaluation revealed that the item did not contribute to the complained event, therefore it was classified as concomitent item.Device was not received.

Event Description

It was reported that patient presented with a trochanteric fracture of left side due to a gunshot wound.Surgeon performed a gamma nail and when surgeon was almost done, the targeting arm would not unscrew.Surgeon had to remove hardware and install a new arm which delayed surgery at least 1 hour as a result.Sales rep clarified that the nail, targeting arm and nail holding screw are stuck together.No issues for locking screw were reported "though they did remove and discard it.When they put new nail in, the length of the screw was no longer correct.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM X 130°
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5239932
• MDR Text Key: 32026297
• Report Number: 0009610622-2015-00546
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 35300380S
• Device Lot Number: K0D6CEC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR