MAUDE Adverse Event Report: SYNTHES USA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: during locking compression plate-distal femur (lcp-df) removal operation, the head of one locking screw became blunt, so the surgeon tried to remove it according to lcp general catalogue.The extraction screw was first used, but it got broken, so the carbide drill was used instead.The locking screw was successfully removed after drilling with the carbide drill.No broken part remained in the patient.There was a 20-minute delay of the surgery.This report is on the unknown extraction screw.This is 2 of 2 reports for complaint (b)(4).

Manufacturer Narrative

This device used for treatment and not diagnosis.This report is on an unknown extraction screw, part and lot numbers are unknown.Without a part number the 510k number cannot be provided.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Placeholder.

• Manufacturer (Section D): SYNTHES USA; west chester PA 19380
• Manufacturer Contact: sherry laing ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3636594
• MDR Text Key: 3984724
• Report Number: 2520274-2014-00647
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/22/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1