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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA BLADE L110 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA BLADE L110 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.017S
Device Problem Mechanical Jam (2983)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Date of implant reported as 2008, exact date is not known. 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.
 
Manufacturer Narrative
A device history record (dhr) review was performed for part number: 04. 027. 017s, synthes lot number: 2618178: release to warehouse date: 29. Jun. 2010 expiry date: 01. Jun. 2020, manufacturing site: (b)(4): no non-conformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Product was not returned. The device history record was researched; no abnormal findings were identified. Manufacturing and inspection records indicated no problems with the lot in question. Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformance. Based on the information available, 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. The received pictures and x-ray confirm the issue as per event description; the complaint therefore has been determined to be confirmed. 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.
 
Manufacturer Narrative
Patient id/initials, age/date of birth and weight are unknown. Complainant part is not expected to be returned for manufacturer review/investigation. G5: 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. 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 in (b)(6) as follows: it was reported the patient was implanted with a less invasive stabilization system (liss) and a proximal femoral nail anti-rotation (pfna) after a motorcycle accident in 2008, due to a complex multiple supply cut of the right thigh. The patient was free of symptoms. Recently the patient had a further accident where he had a collision with a tree trunk. The patient suffered a break to the thigh between the liss and pfna. An implant removal with new nailing was planned. During surgery, they were not able to remove the blade. The surgery was finished, and an additional surgery with additional instruments was successfully completed on (b)(6) 2017. Concomitant device: pfna nail (part 472. 401s, lot 2519028, quantity 1). This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA BLADE L110 TAN
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7219360
MDR Text Key253076837
Report Number8030965-2018-50598
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819332294
UDI-Public(01)07611819332294(17)200601(10)2618178
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,Followup,Followup,Followup
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2020
Device Catalogue Number04.027.017S
Device Lot Number2618178
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 Received04/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/29/2010
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: 01/25/2018 Patient Sequence Number: 1
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