MAUDE Adverse Event Report: STRYKER GMBH (MDR) INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO; PIN, FIXATION, SMOOTH

Catalog Number ST0A16P

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/09/2015

Event Type  Injury  

Event Description

It was reported that a memometal toe implant failed requiring a revision.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event that smarttoe implant had a breakage after surgery could be confirmed by x-rays.Based on investigation, the root cause of the determined breakage was attributed to a user related issue: the smarttoe implant was not implanted and positioned in a correct manner by the surgeon.A clinicians¿ review of the available medical reports notes: ¿the filed x-ray presents arthrodeses of the pip joints d ii and d iii at the right foot and d iii at the left foot, each fixed with a smart toe.Both smart toes, which have been inserted in the third toe, were broken after approx.Two and six weeks respectively.Both affected smart toes have been implanted in an incorrect manner, whereby both were not correctly positioned inside the marrow cavity of the proximal phalanx and both were (at least partly) outside the bone.The function of the smart toe is based on a correct intramedullary implantation with support of the bone wall on the full length of the device.A perforation of the cortex or a position (partly) outside the bone reduces the range of spring causing peak loads, which may result in implant breakage.Breakage of a smart toe is a rare event.(b)(4).Therefore, from a clinical point of view the incident gives no reason to check the implant design.Corrective actions in the field of the implant design are not required from a clinical point of view.Proposal for changes or adjustments of the instructions for use and the operative technique: the correct surgical technique is step by step described in the operative technique.From the authors¿ point of view all instructions in the operative technique are clearly verbalized and easily understandable to a clinical expert.Therefore, corrective actions in the field of users¿ information are not required.¿ 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.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 a memometal toe implant failed requiring a revision.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer (Section G): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4547965
• MDR Text Key: 5524646
• Report Number: 0008031020-2015-00081
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: ST0A16P
• Device Lot Number: F004421PCAU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2013
• 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): Required Intervention