MAUDE Adverse Event Report: SYNTHES (USA); NAIL, FIXATION, BONE

Device Problem Mechanical Jam (2983)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/28/2012

Event Type  Injury  

Event Description

Attorney advised that a male patient underwent an open reduction internal fixation of the left patella on (b)(6) 2012.In the placement of the locking bolt, the bolt bound up and could not be removed.It was reported that the doctor inspected the back table which showed metal shavings where the locking bolt and nail were originally placed.The set screw was fully deployed or deployed distally which caused binding of the blade through the nail.During the attempted removal of the nail and bound blade, the lateral cortex of the patient split approximately half the length of the femur.This is report 2 of 4 for complaint (b)(4).This report is for an unknown nail.

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown nail.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.

Manufacturer Narrative

This medwatch is being rescinded.The complaint was reviewed on 05/05/2014 and determined to be a duplicate complaint of an existing catsweb complaint management system complaint (b)(4).Complaint (b)(4) was previously reported through mfr# 3003506883-2012-00168.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: NAIL, FIXATION, BONE
• 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: 3687128
• MDR Text Key: 4302225
• Report Number: 2520274-2014-10324
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2014

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?: No
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 03/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention