MAUDE Adverse Event Report: SYNTHES SYNTHES MODULAR HAND SYSTEM; BONE FIXATION

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Entrapment of Device (1212)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/21/2016

Event Type  Injury  

Event Description

While using the synthes modular hand system for a metacarpal fracture, 2 screw heads fell off during the procedure.One from a 1.5mm screw and one 1.3mm screw.The 2 screw shafts remain as part of the implant in the pt.

• Brand Name: SYNTHES MODULAR HAND SYSTEM
• Type of Device: BONE FIXATION
• Manufacturer (Section D): SYNTHES
• MDR Report Key: 5781742
• MDR Text Key: 49254334
• Report Number: MW5063312
• Device Sequence Number: 1
• Product Code: NDJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2016

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 YR