MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD; PIN, FIXATION, SMOOTH

Catalog Number ST016P

Device Problem Structural Problem (2506)

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

Event Date 10/21/2014

Event Type  malfunction  

Event Description

It is reported by the hospital that the implant did not open.A replacement was available.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the reported event that smart toe implant had no expansion during surgery could not be confirmed since the returned device is conforming to specification.Therefore, the case could be classified as a non-issue.Based on investigation, the root cause of the determined no expansion problem was attributed to a user related issue.The smart toe implant expansion problem was caused by mismanagement of the temperature.When the blood is arrested for a long period, the smart toe can take longer to expand because the temperature of the body is too low.Using warm sterile solution between 37°c and 40°c to bath phalanges allows the smarttoe implant to expand properly.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Indications for any material, manufacturing or design related problems were not determined in the investigation.If any further information is provided, the investigation report will be updated.

Event Description

It is reported by the hospital that the implant did not open.A replacement was available.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4260698
• MDR Text Key: 5029057
• Report Number: 0008031020-2014-00552
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/22/2014

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: 01/31/2019
• Device Catalogue Number: ST016P
• Device Lot Number: F005082PDAI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2014
• 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: 57 YR