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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 Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for unknown quantity of unknown nail. Part#, lot# and udi # is not available. Device was not explanted. Two unsuccessful attempts were made. Device is not expected to be returned for manufacturer review/investigation. (b)(6). This report is for unknown quantity of unknown nail. Pma/510(k) number is not available. (b)(4). 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 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 europe reports an event in (b)(6) as follow: it was reported that a patient underwent initial implant procedure in italy after an accident sometimes in 2015. In (b)(6) 2016, patient underwent a first removal surgery for proximal femoral nail antirotate (pfna). They tried to remove the nail and the blade but it was not possible. The implants were left in the patient. On (b)(6) 2016, patient underwent second removal surgery to remove implants. The second attempt was also not successful. Second attempt of removal surgery will be captured under (b)(4). This report is for unknown quantity of unknown nail ¿ attempted to remove during the first revision surgery. This is report 2 of 3 for (b)(4).
 
Manufacturer Narrative
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
Patient was reported as active and athletic.
 
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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 Key6200150
MDR Text Key63176331
Report Number2520274-2016-15762
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,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
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 Received02/09/2017
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

Patient Treatment Data
Date Received: 12/22/2016 Patient Sequence Number: 1
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