MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SMART TOE IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/22/2014

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a literature published by regional orthopaedic hospital, in ireland.The title of this report is ¿use of smart toe implant for small toe arthrodesis: a smart concept?¿ which is associated with the stryker ¿smart toe¿ system.The article can be found at pubmed with id 25937410.Within that publication, post-operative complications/ adverse events were reported, which allegedly occurred from february 2011 to december 2012.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, 8 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses metal cut-out followed by revision surgery including its removal.2 out of 2 cases.The report states: ¿there were two cases of implant cut out.All cut outs were distal and in the dorsal direction.The first patient was a (b)(6) year-old female and the second was a (b)(6) year-old female.Neither of the two patients was diabetic.The implant was seen to have cut out of the distal fragment at the 2-week review of the two patients.Both patients underwent revision surgery.The implant was removed and fixation was done with kirschner wires.Both patients eventually united, albeit at 8 and 10 weeks ¿.

• Brand Name: UNKNOWN SMART TOE IMPLANT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10199957
• MDR Text Key: 198103841
• Report Number: 0008031020-2020-01773
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: IE
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• 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
• Patient Age: 49 YR