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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Collapse (2416); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(6). This report is for two (2) unknown locking bolts. Per facility, the complainant parts will not be returned for manufacturer review/investigation. (b)(4) patient¿s collapsed femoral neck and head bone. Pma/510k: unknown, as specific part and lot numbers for the complainant bolts were not provided. However, the likely 510k (based on the type of construct) is k131548. Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. 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 a patient was originally treated for a hip fracture with the implantation of a trochanteric femoral nail advanced (tfna) system on (b)(6) 2016. The construct included the following devices: one (1) femoral nail, one (1) lag screw, and two (2) locking bolts. On an unknown post-operative date, the patient presented with a collapsed femoral neck and femoral head bone. As a result, the patient was returned to the operating room for revision surgery on (b)(6) 2016. During the revision, the surgeon successfully removed all of the original tfna hardware with no reported issues. The patient was then revised to a depuy total hip replacement. The patient's status post-operatively was reported as stable. This report is for two (2) unknown locking bolts. This report is 3 of 3 for (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 (Section G)
SYNTHES USA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5632344
MDR Text Key44449451
Report Number2520274-2016-12547
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 04/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID NumberUNKNOWN
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 Received04/14/2016
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

Patient Treatment Data
Date Received: 05/04/2016 Patient Sequence Number: 1
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