MAUDE Adverse Event Report: SYNTHES (USA) 2.0MM KIRSCHNER WIRE W/15MM; MANDIBLE DISTRACTION DEVICES

Catalog Number 292.79

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that while the surgeon was performing a right femoral osteotomy using a locking compression/pediatric hip plate, the tip of one of 2.0 k wires, part 292.79, broke off into femoral head.The tip was left in patient.The surgery was completed successfully and there was no surgical delay.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM KIRSCHNER WIRE W/15MM
• Type of Device: MANDIBLE DISTRACTION DEVICES
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4522023
• MDR Text Key: 5410426
• Report Number: 2520274-2015-10989
• Device Sequence Number: 1
• Product Code: MQN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.79
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 67