MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SMART TOE 19-MM STRAIGHT; IMPLANT

Catalog Number UNK_SEL

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 06/17/2013

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 st.John hospital and medical center, in usa.The title of this report is ¿smart toe® implant versus buried kirschner wire for proximal interphalangeal joint arthrodesis: a comparative study¿ which is associated with the stryker ¿smart toe¿ system.The article can be found at https://doi.Org/10.1053/j.Jfas.2013.02.007.Within that publication which included 58 patients, post-operative complications were reported, which allegedly occurred from 1 january 2007 to 31 december 2010.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, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses (2) cases of implant fracture.The report states: ¿fracture of internal fixation occurred in 12 (20.7%) of the smart toe implants and 2 (7.1%) of the buried k-wires.Of the 12 fractured smart toe implants, 7 (58.3%) were 16-mm straight, 3 (25%) were 16-mm angulated, 2 (16.7%) were 19-mm straight, and 0 were 19-mm angulated.Revision surgery was needed in 5 (8.6%) of the smart toe and 3 (10.7%) of the buried intramedullary k-wire implants.¿.

• Brand Name: UNKNOWN SMART TOE 19-MM STRAIGHT
• 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: 10381458
• MDR Text Key: 203162573
• Report Number: 0008031020-2020-02109
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/07/2020
• 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