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

Catalog Number ST016P

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Date 02/24/2015

Event Type  malfunction  

Event Description

It was reported that implant broke during insertion.Surgeon used another implant to complete surgery.

Manufacturer Narrative

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

Manufacturer Narrative

The reported incident that intramedullary arthrodesis implant smart toe ii 16mm / 10° angle for pip arthro was alleged of issue s-11 (breakage during surgery) could be confirmed.Based on the currently available information, we cannot determine the exact root cause of the issue but, regarding previous investigations, knowledge and experience we have on this product, we know that smart toe can bend when there is a mismanagement of the temperature and/or an overload.It can happen when implant is removed too early from freezer and when surgeon wants to insert it while implant has started to expand.As implant has started to recover its final shape, it is harder to insert it and it creates an overload which deforms and bends the device.Therefore this case is classified as user related.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

It was reported that implant broke during insertion.Surgeon used another implant to complete surgery.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4607430
• MDR Text Key: 5627743
• Report Number: 0008031020-2015-00102
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• 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: F005017P04F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2014
• 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