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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA PFNA Ø10 125° L240 TAN ROD,FIXATION,INTRAMEDULLARY

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SYNTHES USA PFNA Ø10 125° L240 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 472.260S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device is not expected to be returned for manufacturer review/investigation. (b)(4). Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). 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
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a proximal femoral nail antirotation (pfna) blade and nail removal surgery was performed on (b)(6) 2016 due to a collapsed femoral head. A total hip replacement was performed. Patient outcome was reported to be good. Concomitant device reported as: 4. 9mm ti locking bolt 36mm (part # 459. 360, lot # unknown, quantity 1) this is report 1 of 2 for (b)(4).
 
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Brand NamePFNA Ø10 125° L240 TAN
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 Key6181318
MDR Text Key62601300
Report Number2520274-2016-15694
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number472.260S
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 Received11/25/2016
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: 12/16/2016 Patient Sequence Number: 1
Treatment
ONE (1) 4.9MM TI LOCKING BOLT 36MM (459.360)
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