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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER; SCREW,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER; SCREW,FIXATION,BONE Back to Search Results
Catalog Number 04.005.526S
Device Problem Unintended Movement (3026)
Patient Problem Unspecified Infection (1930)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown date in 2019.Device evaluated by mfr: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent a debridement and hardware removal surgery on (b)(6) 2019.The patient was initially with the expert tibial nail system on (b)(6) 2019, due to a fibula diaphyseal fracture.On (b)(6) 2019, the patient visited the hospital and post-operative course was good.(b)(6) 2019, the patient visited the hospital again and reported swelling of the affected area and was suspected of infection.The hospital planned to remove one loosened screw in the debridement surgery.During the debridement surgery, the other screws lost their fixation and the infection spread through the implants from the lesion.The surgeon removed all etn implants and applied a vacuum-assisted closure therapy.The patient is under follow-up and will be applied external fixation after the affected area becomes stable.There is a possibility of lower limb amputation due to gangrenous five fingers.The surgeon reported that after (b)(6) 2019, the patient developed purulent meningitis from an unknown cause and there was no problem with the devices.There was a surgical delay of ninety (90) minutes.Procedure and patient outcome are unknown.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 36mm f/im nail-ster.This is report 3 of 7 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.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.Part: 04.005.526s.Lot: 2l06942.Manufacturing site: selzach.Supplier: früh verpackungstechnik ag.Release to warehouse date: 26.October 2018.Expiry date: 01.October 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile 04.05.526 / 1l98438 was manufactured in mezzovico.Part: 04.005.526.Lot: 1l98438.Manufacturing site: mezzovico.Release to warehouse date: 16.October 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
 
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Brand Name
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8569472
MDR Text Key143705949
Report Number8030965-2019-63333
Device Sequence Number1
Product Code HWC
UDI-Device Identifier07611819789814
UDI-Public(01)07611819789814
Combination Product (y/n)N
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/03/2019
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 Number04.005.526S
Device Lot Number2L06942
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/03/2019
Initial Date FDA Received05/01/2019
Supplement Dates Manufacturer Received05/21/2019
Supplement Dates FDA Received06/17/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient Weight70
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