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U.S. Department of Health and Human Services

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

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SYNTHES USA ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2017
Event Type  malfunction  
Manufacturer Narrative
This report is for one (1) unknown helical blade. Part and lot numbers are unknown. Without the specific part and lot numbers, te udi is not available. Device is implanted; as such explant date is not applicable. Complainant device is not expected to be returned for manufacturer review/investigation. 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
It was reported the helical blade insertion handle and the connecting screw became extremely loose when inserting the helical blade during a trochanteric fixation nail (tfn) case on (b)(6) 2017, no matter how much it was tightened. The surgical tech took apart the insertion handle (via how it is to be disassembled for cleaning purposes) and reassemble, to make sure it was put together properly. The helical blade was inserted a second time, with the handle and connecting screw continuously being loose. When the surgeon started malletting, the helical blade was in line to impact the nail, but did not go through the assigned cut-out. The flutes of the helical blade were about to pass through the nail, we looked at the x-ray (not available), which showed the most superior portion of the blade, if inserted any further, was going to make contact with the proximal portion of the nail. It was at this time the helical blade was removed. Another tfn locking set was used and attached to the same helical blade and to a different inserter and connecting screw, to which the helical blade was advanced with no further issues. There was a 25-minute surgical delay. The procedure was completed successfully with the patient in stable condition. Concomitant devices reported: mallet hammer (part # unknown, lot # unknown, quantity # unknown). This report is for one (1) unknown helical blade. This is report 2 of 2 for complaint (b)(4).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6718036
MDR Text Key80305067
Report Number2520274-2017-11938
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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