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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem Blood Loss (2597)
Event Date 07/02/2019
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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
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) screws: trauma.This is report 1 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.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 antirotation (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
UNK - SCREWS: TRAUMA
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8837088
MDR Text Key152514108
Report Number8030965-2019-66617
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/02/2019
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
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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