MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965035S

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Device remains implanted and therefore will not be returned at this time. If additional information becomes available it will be provided on a supplemental report.

Event Description

The customer reported to the rep that upon follow up x-ray during fracture clinic the consultant has noticed that screws backed-out of the nail causing the fixation to fail. Date of surgery: (b)(6) 2016. Date that this was noticed: fracture clinic (b)(6) 2016. No adverse events during initial surgery. (b)(6). She has not fallen or used the arm other than with pendula exercises for 2-3 weeks. Three 5mm locking screws backed out. The patient is considering revision to reverse shoulder replacement. If left alone i think her function will be very poor".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 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: 6114752
• Report Number: 0009610622-2016-00511
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 18965035S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/24/2016
• 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 Age: 78 YR
• Patient Outcome(s): Required Intervention