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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 Problem Device Difficult to Maintain (3134)
Patient Problem No Patient Involvement (2645)
Event Date 05/24/2019
Event Type  malfunction  
Manufacturer Narrative
The device was received.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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) 2019, the patient underwent a hardware removal of proximal femoral nail antirotation (pfna) nail, however, an unknown hammer guide within the set did not appear to have the correct thread profile to extract the nail.All instrument were tried within the set but unsuccessful.The team checked all the devices in the set however, nothing seemed to be aligned to pfna nail removal.There were instruments used to remove an unknown helical blade, but, not the nail.Subsequently, the nail was removed using a stryker timex kit.There was a 5 minutes surgical delay.Patient status is unknown.Concomitant devices reported: unknown pfna nail (part# unknown, lot# unknown, quantity 1); unknown helical blade (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 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.Part: 03.010.000, lot: l611067, manufacturing site: haegendorf, release to warehouse date: 16.Nov.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6 investigation summary: the visual inspection of the extraction screw for tibial+femoral nails has shown that the first thread flank at the forefront is flattened.No other damage could be observed.A functional test with an at the cq department available pfna nail (part 472.107s and lot 2243782) was performed and no functional issue could be detected.The extraction screw could be fully inserted and removed without any issue although the thread flank is damaged.The complained malfunction of "nothing seemed to be aligned to pfna nail removal" could not be replicated with the returned device.Dimensional inspection not required as no functional issue was detected.Drawing/specification review: the proximal femoral nail removal set technique guide was reviewed.It is confirmed that the received extraction screw part 03.010.000 is used to remove pfna nails.Based on this information also the received local set list was reviewed and it was found that the extraction screw part 03.010.000 is available in this set.The received extraction screw for tibial+femoral nails is functional as required, nevertheless is the complaint rated as confirmed as the damaged first thread flank indicates that there was an issue during removal.This damage was clearly caused post-manufacturing as the black coating is totally worn away.Without the involved nail the exact caused of the complained occurrence cannot be defined.The damaged thread flank is an indication that the thread of the nail was damaged, for example by any issue during the insertion/removal of the end cap or by cross-threading of the extraction screw, and that finally the damaged nail thread caused the complained occurrence.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
 
Event Description
The extraction screw was used during the procedure.Stryker timex kit was used to remove the nail.The blade was extracted using the depuy synthes kit.
 
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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 Key8717936
MDR Text Key148978165
Report Number8030965-2019-65530
Device Sequence Number1
Product Code HWB
UDI-Device Identifier07611819160361
UDI-Public(01)07611819160361
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
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.010.000
Device Lot NumberL611067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2019
Initial Date Manufacturer Received 05/24/2019
Initial Date FDA Received06/20/2019
Supplement Dates Manufacturer Received06/28/2019
07/22/2019
Supplement Dates FDA Received07/18/2019
08/15/2019
Patient Sequence Number1
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