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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 85MM STERILE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 85MM STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.285S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Injury (2348)
Event Date 04/17/2018
Event Type  Injury  
Manufacturer Narrative
Patient id/initials, age/date of birth and weight are unknown. Due to intra-operative issues, the device was not implanted/explanted. 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 that the open reduction internal fixation (orif) surgery was performed on (b)(6) 2018. During the surgery, the surgeon measured the length for blade insertion while the tip of the guide wire was placed at three to four millimeters (3-4mm) deep from the subchondral bone. He then chose the blade 85mm against the measured length of 85mm. After insertion of the blade, he noticed that the blade cut out the patient¿s bone head. After extracting the blade in question, he realized that actual length was 82mm. By inserting the blade 75mm, he successfully completed the surgery with a less than thirty (30) minute delay. There was no adverse consequence to the patient. This is report 1 of 1 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE 85MM STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7494438
MDR Text Key107595348
Report Number8030965-2018-53616
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819652439
UDI-Public(01)07611819652439
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
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 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.285S
Device Lot NumberH343867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2017
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: 05/08/2018 Patient Sequence Number: 1
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