MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 41301180S

Device Problems Component Falling (1105); Unsealed Device Packaging (1444)

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

Event Date 06/10/2014

Event Type  malfunction  

Event Description

The pharmacist reported the following event : "when opening the packaging, the nurse opened the tyvek and the protective foam was glued.Therefore, the locking screw for the nail fell on the floor.".

Manufacturer Narrative

Evaluation summary: the reported event was not confirmed as it could not be reproduced.Review of the dhr revealed no discrepancies.The item reported was documented as faultless prior to distribution.As the packaging had been opened already the event could not be reproduced.No traces (marks, imprints) of the set screw were found on the surface of the foam, which indicates the item was located in its intended position (rectangular aperture inside the foam block).Due to the significantly wrinkled tyvek® lid it could be assumed that opening was done with high energy.As the review of the dhr of the reported nail kit revealed no discrepancies in the packaging process, the event may rather be linked to inadequate user handling of the package (dropping the set screw during opening the tyvek® lid of the packaging).No non-conformity was identified.

Event Description

The pharmacist reported the following event : "when opening the packaging, the nurse opened the tyvek and the protective foam was glued.Therefore, the locking screw for the nail fell on the floor.".

Manufacturer Narrative

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

• Brand Name: TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 130°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3920940
• MDR Text Key: 4886324
• Report Number: 0009610622-2014-00310
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/13/2014

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 41301180S
• Device Lot Number: K0D4408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 07/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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