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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG LE 130° L320 SST ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG LE 130° L320 SST ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 02.027.223S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative
Part of device remained in patient, so device not considered explanted during procedure on (b)(6) 2018. It is unknown if the complainant part is available to be returned for manufacturer review/investigation, but it 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. 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. A review of the device history records 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 (b)(4) reports an event as follows: it was reported that on (b)(6) 2018, patient underwent hardware removal of proximal femoral nail anti-rotation (pfna). Originally, the device was implanted through closed reduction internal fixation on (b)(6) 2016 due to subtrochanteric femoral fracture (left). After removal of an unknown locking bolt, the unknown blade could not be released but the removal was successful. While hitting out of the nail under control with an imager the distal part of the nail from the locking hole on broke off and remained inside the mark. On the images preoperatively, there was no evidence for any material fracture. It was unknown if there was a surgical delay and adverse event to the patient reported. Patient outcome was unknown. Concomitant device reported: blade (part/lot unknown, quantity 1). Locking bolt (part/lot unknown, quantity 1). This report is for a pfna. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA Ø10 LONG LE 130° L320 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8244113
MDR Text Key132934313
Report Number8030965-2019-59829
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.027.223S
Device Lot Number9543121
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 Received03/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2015
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: 01/14/2019 Patient Sequence Number: 1
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