MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18964050S

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem No Code Available (3191)

Event Date 10/15/2015

Event Type  malfunction  

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

It was reported that the screw head had internally stripped and the surgeon could not advance the screw as a result during a gamma nail procedure.Sales rep reported that surgeon could not remove the screw."the wounds were closed and the screw was left sitting proud from the lateral cortex." event occured during primary surgery.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X50 MM
• 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: 5203946
• MDR Text Key: 30772814
• Report Number: 0009610622-2015-00510
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003018
• 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: 10/15/2015

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: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 18964050S
• Device Lot Number: K021658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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 Weight: 181