MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 15MM / 0° ANGLE FOR PIP ARTHROD; PIN, FIXATION, SMOOTH

Catalog Number ST015P

Device Problem Difficult to Open or Close (2921)

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

Event Date 03/20/2014

Event Type  malfunction  

Event Description

It was reported that the smart toe didn`t open during surgery.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the reported incident could not be confirmed, since the device was not returned for evaluation.Based on investigation and complaint history, the root cause of the determined no expansion was attributed to a user related issue.The smart toe implant no expansion was caused by mismanagement of temperature / use error.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 smart toe implant to expand properly.A review of the device history was not possible because the lot number was not communicated.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 was reported that the smart toe didn`t open during surgery.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 15MM / 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: 3750033
• MDR Text Key: 19972692
• Report Number: 0008031020-2014-00178
• 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: 03/21/2014

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 Catalogue Number: ST015P
• Device Lot Number: 990002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 04/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Other