MAUDE Adverse Event Report: SYNTHES SYNTHES IMF SCREW; 8 MM MID-FACE IMF SCREW

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/10/2016

Event Type  malfunction  

Event Description

Pt was undergoing a orif for a mandible fracture.Surgeon was screwing in a 12mm imf screw, it broke and a piece was retained.Attempts were made to remove the retained but were not successful.It was burned down and a small portion remained.

• Brand Name: SYNTHES IMF SCREW
• Type of Device: 8 MM MID-FACE IMF SCREW
• Manufacturer (Section D): SYNTHES; west chester PA 19380
• MDR Report Key: 5952282
• MDR Text Key: 54927871
• Report Number: MW5064760
• Device Sequence Number: 1
• Product Code: DZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 65