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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 130° L240 SST ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 130° L240 SST ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 272.265S
Device Problems Break (1069); No Apparent Adverse Event (3189)
Patient Problems Fall (1848); No Code Available (3191)
Event Date 04/21/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown date in 2019. This report is for an unknown nail/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. Product was not returned. 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. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient fell after an unknown surgery. Originally, the patient was implanted with proximal femoral nail anti-rotation (pfna) system on unknown date. Patient consequence is unknown. This report is for one (1) nail: pfna. This is report 1 of 3 for (b)(4).
 
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Brand NamePFNA Ø10 130° L240 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 Key8649889
MDR Text Key146368027
Report Number8030965-2019-64625
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 foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number272.265S
Device Lot Number2L38241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/29/2019 Patient Sequence Number: 1
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