MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II; PIN, FIXATION, SMOOTH

Catalog Number UNK_SEL

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

Patient Problem Deformity/ Disfigurement (2360)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

This record is a consolidation of events summarized as part of literature review when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of mallet toe deformity could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition unknown.

Event Description

The manufacturer became aware of a literature published by the ¿orthopaedic surgery and traumatology department, clínica universidad de navarra, spain¿.The title of this report is, ¿the efficacy of an intramedullary nitinol implant in the correction of claw toe or hammertoe deformities¿, published on may 17, 2019, which is associated with the stryker ¿smart toe system¿.This report can be found at https://doi.Org/10.1007/s00402-019-03203-w.This report includes an analysis of the clinical data that was collected on 36 patients, and the cases in this study range from april 2013 to october 2018.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 25 patients experienced mallet toe deformity.The report states, ¿in 70% of the lesser toe deformities operated on, a mallet toe deformity developed, but this was asymptomatic¿.

• Brand Name: UNKNOWN INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15070659
• MDR Text Key: 296288193
• Report Number: 0008031020-2022-00356
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/20/2022

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?: 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
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/20/2022
• 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): Other