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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE; APPLIANCE, FIXATION, NAIL
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OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE; APPLIANCE, FIXATION, NAIL Back to Search Results
Catalog Number 412.214S
Device Problem Device-Device Incompatibility (2919)
Patient Problem Injury (2348)
Event Date 12/04/2019
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation: sterile part 412.214s, lot 1l77781: manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: october 08, 2018.Expiry date: october 01, 2028.Non-sterile part 412.214, lot 1l37392: manufacturing site: (b)(4).Release to warehouse date: september 13, 2018.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformances were identified.A product investigation was completed: reviewing the provided x-ray, the complaint description can be confirmed that the anti-rotation screw is back out post-operatively.It is not possible to identify the root cause for the reported problem without having the complained part available for investigation.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.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 (b)(6) reports an event as follows: it was reported the patient underwent total hip arthroplasty on (b)(6) 2019.The patient reported pain early in november and the cut-out of the implant was found when she got an examination two (2) weeks after the pain recurred.During the surgery, the surgeon had difficulty in extracting the locking screw because it had been fixed to the plate firmly.He removed the locking screw by attaching the insert to the plate and turning a driver with all his strength.Also, the anti-rotation screw could not be removed with a screwdriver because it stopped turning with the screwdriver halfway through.He removed it by clutching the screw.Concomitant device reported: plate 1 hole fracture femoral neck system tan (part 04.168.000s, lot l911548, quantity 1), insertion instruments (part unknown, lot unknown, quantity 1), screwdrivers (part unknown, lot unknown, quantity 1).This report captures the intra-operative event.The post-operative pain/implant cut-out is captured on related complaint (b)(4).This report is for a locking screw.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.
 
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.
 
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Brand Name
5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE
Type of Device
APPLIANCE, FIXATION, NAIL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9535495
MDR Text Key175259373
Report Number8030965-2019-71557
Device Sequence Number1
Product Code KTT
UDI-Device Identifier07611819152359
UDI-Public(01)07611819152359
Combination Product (y/n)N
PMA/PMN Number
K000682
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 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number412.214S
Device Lot Number1L77781
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2020
Patient Sequence Number1
Treatment
PL 1-HO F/FEM NECK SYST TAN; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - SCREWDRIVERS
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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