MAUDE Adverse Event Report: STRYKER CMF LEIBINGER UNIVERSAL MANDIBULAR PLATING SYSTEM; PLATE, BONE, TRAY

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2016

Event Type  malfunction  

Event Description

Upon delivery of requested screw for placement from the (b)(4) universal mandibular plating system (004) kit, the scrub technician noticed debris on screw which compromised the surgical field.The screw was removed from field and a new kit was introduced.

• Brand Name: LEIBINGER UNIVERSAL MANDIBULAR PLATING SYSTEM
• Type of Device: PLATE, BONE, TRAY
• Manufacturer (Section D): STRYKER CMF; 325 corporate drive; mahwah, nj 07430 NJ 07430
• MDR Report Key: 6212962
• MDR Text Key: 63534926
• Report Number: 6212962
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR