MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SMART TOE; IMPLANT

Catalog Number UNK_SEL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

As reported, rep was contacted (b)(6) 2018 by a surgeon in regards to stryker smart toe implants (no specific part/ lot numbers).Surgeon stated he has experienced 10-12 implant failures in 100 cases he has utilized the system.I haven't covered his cases since 2013 (at his request).As a result, i was unaware of these failures until now.This event is for case 8 of 12.

• Brand Name: UNKNOWN SMART TOE
• Type of Device: IMPLANT
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7261494
• MDR Text Key: 99768306
• Report Number: 0008031020-2018-00111
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• 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): Required Intervention