MAUDE Adverse Event Report: SYNTHES USA; CERCLAGE FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient weight is not available for reporting.This report is for two (2) unknown cables.Part#, lot# and udi # is not available.Exact date of implant procedure is unknown.Reportedly, device was implanted four to five months prior to revision surgery on (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.(b)(4).This report is for two (2) unknown cables.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device 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

It was reported that on an unknown date in 2016, a patient underwent and open reduction and internal fixation (orif) procedure and was implanted with a less invasive stabilization system (liss) plate, nine (9) titanium locking screws, and two (2) cables to repair a right periprosthetic femur fracture.Later, it was identified that the patient had developed a non-union at the fracture site and would require revision surgery.On (b)(6) 2016, the patient was returned to the operating room and all of the implanted devices were removed intact without difficulty.During the procedure, the tip of a stardrive screwdriver broke off while it was being used to extract one of the screws.The tip was easily retrieved; however, when the instrument was removed and being washed, the tip was lost down the drain.Another screwdriver was immediately on hand to complete the procedure and there was no surgical delay noted.Patient outcome was not reported.Complaint regarding screwdriver break is captured under (b)(4).This report is for two (2) unknown cables.This is report 3 of 3 for (b)(4).

• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6120336
• MDR Text Key: 60649457
• Report Number: 2520274-2016-15489
• Device Sequence Number: 1
• Product Code: JDQ
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2016

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?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/22/2016
• 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