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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 80MM STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 80MM STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.280S
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight not available for reporting. Date of device migration is not known explant of device was scheduled for (b)(6) 2018. Removal has not been confirmed. Complainant part is not expected to be returned for manufacturer review/investigation. Dhr review was completed. Part number: 04. 038. 280s. Lot number: h286498. Part manufacturing date: 10 march 2017. Manufacturing site: (b)(4). Part expiration date: 01 march 2027. Nonconformance noted: n/a. A review of the device history record revealed no complaint related anomalies. The device history record shows lot h286498 of tfna helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted. This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record(s) determined the raw material lot 9974143 met all specifications with no issues documented that would contribute to this complaint condition a review of the device history record revealed no complaint related anomalies. This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 patient underwent an open reduction internal fixation (orif) using the trochanteric fixation nail advanced (tfna) system for a jensen type 3 femoral trochanteric fracture on (b)(6) 2018. On (b)(6) 2018, it was confirmed that the tfna helical blade has cut out. Surgeon stated that the nail was inserted slightly posterior and that a longer nail should have been selected for implant. Patient is reported to visit the hospital on a regular basis. Patient is scheduled for return to surgery on (b)(6) 2018 for removal of the implants. Due to patient¿s age, revision to new hardware is not being considered at this time. It is not known if the removal procedure has taken place. Concomitant devices reported: 5. 0mm locking screw with t25 stardrive 34mm for im nail (04. 005. 524s, lot l694446, quantity 1); 10mm 125 degree cannulated tfna nail 170mm (04. 037. 012s, lot h521782, quantity 1); end cap for tfna 0mm extension (04. 038. 000s, lot l590134, quantity 1). This report is for one (1) tfna helical blade 80mm. This is report 1 of 1 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE 80MM 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 Key7837069
MDR Text Key118895826
Report Number8030965-2018-56102
Device Sequence Number1
Product Code HSB
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 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.280S
Device Lot NumberH286498
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 Received09/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2017
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: 08/31/2018 Patient Sequence Number: 1
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