MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SMARTOE IMPLANT 3

Catalog Number UNK_SEL

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

Patient Problem Implant Pain (4561)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.

Event Description

A patient reported the following: the patient had pins implanted in 2012.3 pin were implanted and right away one broke on the patient's right foot.The second toe has half the implant, the third toe from the big toe is the worst case where the toe is to the side and the patient can feel "something" and it hurts.The patient cannot wear close toed shoes anymore.She had x-rays taken and it shows that the toe turning to the side and the implant being straight the patient feels a lot of discomfort.The fourth toe from the big toe seems to be progressing in the same way as the third toe.A second procedure was conducted were half a pin was taken out and the toe was made shorter in 2012, this happened a couple of months after the first procedure.The pain did not persist after this procedure patient just has a shorter toe (next to the big toe).The third toe has a bump where the implant is and it hurts is the toe that patient is facing issues with currently.This issue started in 2021, the issue with the toe turning was a slow gradual process.Patient has a new doctor who does not know how to take this pin out.The original surgeon has retired.

• Brand Name: UNKNOWN SMARTOE IMPLANT 3
• Type of Device: IMPLANT
• 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: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12577125
• MDR Text Key: 274916211
• Report Number: 0008031020-2021-00428
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2021

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
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/05/2021
• 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: 50 YR
• Patient Weight: 54