MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965045S

Device Problem Unsealed Device Packaging (1444)

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

There were 2 units from this same lot in the storage area belonging to the sales rep.The primary package were opened.The other one has the secondary package still closed and they will return it for analysis.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: no deviation found in manufacturing.No discrepancies found regarding risk analysis.Review of the manufacturing for lot k212439 confirmed that the cardboard boxes were sealed with a shrink wrap prior to initial distribution.The packaging was corresponding to its specifications at time of initial distribution.Investigation revealed that an already opened secondary packaging (cardboard box) containing an already opened primary packaging (blister) had been overwrapped again at the distribution site and then was distributed to the end user.The manufacturer stryker kiel has validated packaging processes and the packaging design as well.In this case the packaging design was modified unauthorized at the distribution site (removal of the original overwrap and replacement by other not validated overwrap).The nonconformance (open primary packaging inside box) was caused by unauthorized and not validated re-packaging at the distribution site.The manufacturer rejects the responsibility for not authorized re-packaging practices at the distribution site.

Event Description

There were 2 units from this same lot in the storage area belonging to the sales rep.The primary package were opened.The other one has the secondary package still closed and they will return it for analysis.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
• 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: 3903977
• MDR Text Key: 4519064
• Report Number: 0009610622-2014-00303
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2014

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: Lay User/Patient
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 18965045S
• Device Lot Number: K212439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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