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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L95 TAN ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L95 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.054S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 03/12/2018
Event Type  Injury  
Manufacturer Narrative
Patient information not available for reporting. Device malfunctioned intra-operatively and was not implanted / explanted. Date returned to manufacturer device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4) - no code available used to capture change in surgical plan. Surgeon used a different size blade than originally planned. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 patient underwent an open reduction internal fixation (orif) for a femoral trochanteric fracture on (b)(6) 2018. Implanted during the procedure was a proximal femoral nail antirotation (pfna) nail, pfna blade, and unknown quantity of locking screws and end caps. During the procedure, after insertion of the pfna blade, surgeon attempted to lock the blade but was not successful. Surgeon then used a different pfna blade of a different size and was able to successfully lock it to the nail. Surgery was completed successfully with no adverse consequence to the patient. Concomitant devices reported: pfna nail (part number unknown, lot number unknown, quantity 1), locking screw (part number unknown, lot number unknown, quantity unknown), end cap (part number unknown, lot number unknown, quantity unknown). This report is for one (1) pfna blade. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L95 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 Key7399480
MDR Text Key104460888
Report Number8030965-2018-52793
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
Type of Report Initial,Followup
Report Date 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.054S
Device Lot NumberL360623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/05/2018 Patient Sequence Number: 1
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