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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.053S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2018
Event Type  Injury  
Manufacturer Narrative
Patient weight is unknown. Additional procode: ktt. Device malfunctioned intra-operatively and was not implanted / explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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. A device history records review has been requested. 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 that the surgeon used the proximal femoral nail antirotation (pfna) system for a surgery. During the surgery, the pfna blade (90 mm) didn't lock inside. The surgeon tried twice but finally gave up as the blade was constantly moving inside the femoral neck. He instead used a 95 mm blade to complete the surgery. The surgery was delayed approximately 40 minutes, and was completed successfully. Patient status is unknown. This complaint is for a pfna-ii blade l90 tan. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L90 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 Key7523839
MDR Text Key108600988
Report Number8030965-2018-53822
Device Sequence Number1
Product Code HSB
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
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.053S
Device Lot NumberL679515
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 Received04/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/05/2017
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: 05/17/2018 Patient Sequence Number: 1
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