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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE; APPLIANCE,FIXATION,NAIL
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OBERDORF SYNTHES PRODUKTIONS GMBH FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE; APPLIANCE,FIXATION,NAIL Back to Search Results
Model Number 04.168.000S
Device Problem Device-Device Incompatibility (2919)
Patient Problem Blood Loss (2597)
Event Date 07/02/2019
Event Type  Injury  
Manufacturer Narrative
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) 2018, the fns was implanted to the patient for garden 4 type fracture.On an unknown date after the initial surgery, the implant was removed.On (b)(6) 2019, the fns removal and bipolar hip arthroplasty surgery was performed.In the re-operation, the screw could not be removed.The surgeon used a carbide drill to break the screwhead and removed the plate.He removed the screw by unknown removal devices subsequently.The artificial femoral head was introduced successfully.The surgery was delayed by forty-five (45) minutes.There was an extra bleeding and a greater risk of infection because of the surgical delay.It is unknown if the metallic powder of the screw remained in the patient body.Concomitant device reported: unk - nail head elements: fns antirotation (part#unknown, lot#unknown, quantity#1); fns plate (part#04.168.000s, lot# l642150, quantity#1); unk - nail head elements: fns bolt (part#unknown, lot#unknown, quantity#1) this report is for one (1) femoral neck system plate1 hole - sterile this is report 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.H11 corrected data: d4: udi number, g1: physical manufacturer.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 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.H11 corrected data: b5, d11: corrected concomitant devices.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
This (b)(4) captures the intraoperative event for the re-operation wherein the unk screw/s could not be removed easily, while, (b)(4) captures the postoperative event for the implanted fns cut-out.Concomitant device reported: unk - nail head elements: fns antirotational (part#unknown, lot#unknown, quantity#1) and unk - nail head elements: fns bolt (part#unknown, lot#unknown, quantity#1).
 
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Brand Name
FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
Type of Device
APPLIANCE,FIXATION,NAIL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8837158
MDR Text Key152520628
Report Number8030965-2019-66619
Device Sequence Number1
Product Code KTT
UDI-Device Identifier10886982274557
UDI-Public(01)10886982274557
Combination Product (y/n)N
PMA/PMN Number
K172872
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number04.168.000S
Device Catalogue Number04.168.000S
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2019
Patient Sequence Number1
Treatment
PL 1-HO F/FEM NECK SYST TAN; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - NAIL HEAD ELEMENTS: FNS BOLT; PL 1-HO F/FEM NECK SYST TAN; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT
Patient Outcome(s) Required Intervention;
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