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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L100 TAN ROD,FIXATION,INTRAMEDULLARY

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OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L100 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.055S
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  malfunction  
Manufacturer Narrative
Dhr review was completed. Part number: 04. 027. 055s. Synthes lot number: l518734. Release to warehouse date: 09. Aug. 2017. Expiry date: 01. Aug. 2027. Manufacturing site: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 status reported as okay.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. No patient information is available for reporting. Device is not considered implanted or explanted as it broke intraoperatively and was not able to be implanted. Device return is unknown. Contact phone number is unavailable. Device is not distributed in the united states, but is similar to device marketed in the usa. 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported during surgery on (b)(6) 2017 a proximal femoral nail antirotation (pfna) blade broke intraoperatively. No fragments were left behind in the patient. A surgical delay of 10 minutes was noted. Procedure was completed successfully. Patient status is unknown. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L100 TAN
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7154705
MDR Text Key255276582
Report Number8030965-2017-51014
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819394247
UDI-Public(01)07611819394247(17)270801(10)L518734
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.055S
Device Lot NumberL518734
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 Received01/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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