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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L105 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L105 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.056S
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa. An aqua colored fragment of the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an implant surgery with the proximal femoral nail antirotation-ii (pfna-ii) system. When the surgeon tried to close an incision after implanting, he found that a metallic fragment remained on the soft tissue. The surgeon could remove the fragment, and the surgery was finished. The fragment might be generated from the implants. Patient outcome is reported as stable. Only the fragment will be shipped for investigation, and the implants will not be shipped. No further information is available. Concomitant device reported: guide wire (part #: 356. 830s, lot #: unknown, quantity #1). This report is for one (1) pfna-ii blade. This is report 2 of 2 for complaint (b)(4).
 
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Brand NamePFNA-II BLADE L105 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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9152516
MDR Text Key194681700
Report Number8030965-2019-68980
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 09/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.056S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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