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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 Problems Bent (1059); Migration or Expulsion of Device (1395)
Patient Problems Failure of Implant (1924); Sedation (2368); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(6). (b)(4). Original implant date unknown. Not explanted, nail remains in patient leg. Device is not expected to be returned for manufacturer review/investigation. (b)(4). Subject device has not been received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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 patient experienced another fracture, at the previously treated fracture site with a nail, due to trauma. The patient was initially implanted with lateral entry femoral nail on an unknown date. The patient then had a motorcycle accident and fractured the distal third part of the femur around the nail. The surgeon intended to remove the synthes nail and insert a competitor's retrograde nail. The surgeon removed the interlocking screws and connected a non-synthes conical nail extractor to the nail. He attempted to back slap it multiple times and was unsuccessful at extracting the nail. He then decided that the only option was to re-insert interlocking screws and complete surgery. It was determined the nail was bent during the accident which would not permit it to be extracted. Patient outcome: the nail remained in the patient and leg mal-aligned. There was a 30 minute surgical delay. Surgery completed successfully. This complaint is for 1 device. Concomitant devices: unknown screw (part unknown, lot unknown, quantity unknown). This report is 1 of 1 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 Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5644813
MDR Text Key44886355
Report Number2520274-2016-12626
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 04/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2016
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: 05/10/2016 Patient Sequence Number: 1
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