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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L100 SST ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L100 SST ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 02.027.035S
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Case number for implantation procedure reported as (b)(6). Date of event is an unknown date in 2019. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(4). 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 (b)(6) reports an event as follows: it was reported that patient was treated for a left sided pertrochanteric femur fracture on the (b)(6) 2019. A proximal femoral nail antirotation (pfna) nail and blade were inserted to fix the fracture. Postoperatively, the patient experienced pain, and it was noted that the blade had moved into the hip joint. Revision surgery was performed on (b)(6) 2019. Concomitant devices: screw (part: 259. 400, lot: 3l77106, quantity: 1), proximal femoral nail antirotation (pfna) nail (part: 272. 266s, lot: 4l08383, quantity: 1). This report is for a pfna helical blade. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA BLADE PERF L100 SST
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 Key9511391
MDR Text Key186821892
Report Number8030965-2019-71367
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
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.027.035S
Device Lot Number3L77106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/23/2019 Patient Sequence Number: 1
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