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

Device Problem Separation Failure (2547)

Patient Problem Tissue Damage (2104)

Event Date 01/27/2014

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: in (b)(6), multiloc humeral nailing system was used for a surgical neck fracture case.In mid-january, the reduction of the bone head was found to be collapsed.The surgeon decided to replace it with an artificial bone head.On (b)(6), nail removal and bone head replacement surgery was performed.When extracting the screw-in-screw in the proximal a hole, it spun around and couldn¿t be removed.(the driver could engage the recess of the screw head, and move counterclockwise).In this surgery, the incision was made by deltopectoral approach, so the surgeon opened the surgical site and removed the screw by grasping the screw shaft inside the bone head and pushing it out.This report is for 1 unknown nail.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

This report is for 1 unknown nail implant date reported as (b)(6) 2013 investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Report should be for both adverse event and product problem.Report is for an unknown nail so 510k number is not known.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 4 for complaint (b)(4).

• 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: 3644101
• MDR Text Key: 4184668
• Report Number: 2520274-2014-10006
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000684
• 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,Followup
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• 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?: Yes
• Date Manufacturer Received: 04/30/2014
• 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
• Patient Age: 70 YR