MAUDE Adverse Event Report: SYNTHES USA; ROD,FIXATION,INTRAMEDULLARY

Device Problems Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371)

Patient Problem Sedation (2368)

Event Date 02/22/2016

Event Type  Injury  

Manufacturer Narrative

Report is for one (1) unknown bar (rod).(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.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a surgical procedure, the surgeon was placing four (4) locking caps; however the bar would not hold the screws which forced the surgeon to use a reduction instrument.The reduction instrument became stuck on the screw and disarmed which caused the screws to shift.The surgery was prolonged about 60 minutes; however there was no patient harm reported.This report is for one (1) unknown bar (rod).This is report 7 of 7 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: 5484479
• MDR Text Key: 39839667
• Report Number: 2520274-2016-11518
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• 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
• Date Manufacturer Received: 02/22/2016
• 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