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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR
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OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR Back to Search Results
Catalog Number 03.010.000
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 07/07/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Part number: 03.010.000.Lot number: 4l09860.Manufacturing site: (b)(4).Release to warehouse date: 15.May 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that a tibial nail was removed from the patient.The extraction screw was faulty due to the threads.An additional extraction screw was used however the thread on the nail had been destroyed.A guide wire was put down and an extraction conical bolt was used to remove the nail.There was a surgical delay of sixty (60) minutes and the procedure was completed successfully.This report is for one (1) conical extraction screw for ti femoral and tibial nails.This is report 1 of 3 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.The complaint condition, that the threads of the extraction screw are damaged, could be confirmed according to the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.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.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.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This instrument complain assessed by the engineer.As can be seen from the attached photographs the thread of this 03.010.000 extract scr f/tibial+fem nails has been damaged.The threads are flattened and badly burred.The lot i/d of this instrument is 4l09860.After a visual inspection per guidance provided in windchill document.It is determined that the reusable instrument is worn from repeated use and service; therefore, further investigation for the reported complaint device is not required.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventative action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market surveillance activities.This instrument will be disposed of.Device history lot part number: 03.010.000, lot number: 4l09860, manufacturing site: haegendorf, release to warehouse date: may 15, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
Additional event description removal of tibial nail case at kenepuru hospital.Rep was not on site.Received call about the extraction screw being faulty.Surgeon tried to use it but thread was no good.I grabbed the tibial nail set from the hospital i was at and drove across town to help.Surgeon tried the new extraction screw i had brought and he ended up threading it due to the thread on the nail now being destroyed.We then put a guide wire down and used a extraction conical bolt to remove the nail.The surgery was delayed 60 minutes.There was no patient consequence.
 
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Brand Name
CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
Type of Device
EXTRACTOR
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10320038
MDR Text Key200447848
Report Number8030965-2020-05239
Device Sequence Number1
Product Code HWB
UDI-Device Identifier10886982066916
UDI-Public10886982066916
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,Followup,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.010.000
Device Lot Number4L09860
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/07/2020
Initial Date FDA Received07/24/2020
Supplement Dates Manufacturer Received08/12/2020
09/09/2020
09/25/2020
Supplement Dates FDA Received09/07/2020
09/09/2020
09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK - EXTRACTION INSTRUMENTS: TRAUMA; UNK - NAILS: TIBIAL
Patient Outcome(s) Required Intervention;
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