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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM-STERILE; APPLIANCE,FIXATION,NAIL
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OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM-STERILE; APPLIANCE,FIXATION,NAIL Back to Search Results
Catalog Number 280.100S
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is not available for reporting.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review has been requested.Device was used for treatment, not diagnosis.
 
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during implanting the lag screw, it did not fit into the dynamic hip plate (dhs).The customer took out the lag screw and tested it on a new plate.It appeared that the problem was the lag screw because it didn't fit.There was a 20 minute delay but no harm to patient.Procedure; proximal femur / hip fracture using dynamic hip system (dhs).This complaint involves one (1) dhs/dcs-scr ø12.5 l110 sst.This report is 2 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: part: (b)(4), lot: l554988 , manufacturing site: (b)(6).Release to warehouse date:(b)(6) 2017, expiry date: (b)(6) 2027.The device history record shows this lot of 24 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.The complaint is confirmed as dhs/dcs screw does not fit into the also received plate.A manufacturing evaluation was performed, and no complaint related issues were found.The device was manufactured according to the specification.This lot of 24 pieces was manufactured in october 2017, all parts are shipped, and we are not aware of any other complaint for this article- and lot combination.The evaluation has shown that the slotted end of the dhs/dcs screw is badly damaged with a clearly visible deformation, which makes an insertion of the plate impossible.The damages were clearly caused post-manufacturing.However, based on the provided information the exact cause of this occurrence cannot be defined.We can only assume that forcible/inappropriate use during insertion of the dhs/dcs screw did lead to the complained malfunction.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Added concomitant device.Reporter's name; 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
Concomitant device reported: locking compression plate (lcp) dynamic hip system (dhs) ( part #02.224.224s, lot # l832015, quantity # 1).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 united kingdom as follows: it was reported that on (b)(6) 2018, patient underwent procedure for proximal femur/hip fracture using dynamic hip system (dhs).During implanting the lag screw, it did not fit into the dynamic hip plate (dhs).The customer took out the lag screw and tested it on a new plate.It appeared that the problem was the lag screw because it didn't fit the new plate.Second lag screw was used, and it worked with the first plate.Dhs plate and the new lag screw were implanted in the patient.Procedure was completed successfully with twenty (20) minutes delay.There was no harm to patient.This report is for one (1) dhs/dcs lag screw.This is report 1 of 1 for (b)(4).
 
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Brand Name
DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM-STERILE
Type of Device
APPLIANCE,FIXATION,NAIL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7910444
MDR Text Key121858340
Report Number8030965-2018-56689
Device Sequence Number1
Product Code KTT
UDI-Device Identifier07611819055292
UDI-Public(01)07611819055292
Combination Product (y/n)N
PMA/PMN Number
K791619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number280.100S
Device Lot NumberL554988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2018
Date Manufacturer Received11/15/2018
Patient Sequence Number1
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