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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA Ø9 130° L240 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA Ø9 130° L240 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 472.401S
Device Problem Bent (1059)
Patient Problems Bone Fracture(s) (1870); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient¿s identifier, date of birth/age and weight are unknown. Date of event is unknown. Implanted in 2008; exact date is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). The nail was bent requiring revision surgery. 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 europe reports an event in (b)(6) as follows: it was reported the patient was implanted with a less invasive stabilization system (liss) and a proximal femoral nail anti-rotation (pfna) after a motorcycle accident in 2008, due to a complex multiple supply cut of the right thigh. The patient was free of symptoms. Recently the patient had a further accident where he had a collision with a tree trunk. The patient suffered a break to the thigh between the liss and pfna. An implant removal with new nailing was planned. During surgery, they were not able to remove the blade. The surgery was finished, and an additional surgery with additional instruments was successfully completed on (b)(6) 2017. After the removal, it became apparent that the pfna nail was bent by the new accident. This is evident in hindsight or on the x-ray screen. This also explains why the blade had jammed in the nail and so caused significant difficulties during hardware removal. This report captures the postoperative bent nail. The event of postoperative jammed blade during hardware removal procedure has been captured under linked complaint (b)(4). Concomitant devices reported: pfna blade (part # 04. 027. 017s, lot # 2618178, quantity 1); liss plate (part # unknown, lot # unknown, quantity 1); unknown screws (part # unknown, lot # unknown, quantity unknown). This report is for one (1) pfna nail. This is report 1 of 1 for complaint (b)(4).
 
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Brand NamePFNA Ø9 130° L240 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7259174
MDR Text Key99602520
Report Number8030965-2018-50988
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2019
Device Catalogue Number472.401S
Device Lot Number2519028
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 Received04/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/20/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/09/2018 Patient Sequence Number: 1
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