MAUDE Adverse Event Report: STRYKER K-WIRES; PIN, FIXATION, SMOOTH

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

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Open reduction internal fixation (orif) of left first metatarsal was performed on an unknown date in (b)(6) 2015.Post-operatively due to continued pain and prominent hardware, a revision surgery was performed on (b)(6) 2016 to explant plate and three (3) broken screws.Patient also had additional screws that were not explanted and also there were other implants, it was unknown whether they were explanted or remained in the patient.In addition, patient also had two (2) stryker k-wires.The patient was involved in a motor vehicle accident (mva) one year prior to implant.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: K-WIRES
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17528308
• MDR Text Key: 321134450
• Report Number: MW5135239
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1