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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 Problems Blood Loss (2597); No Code Available (3191)
Event Date 08/19/2019
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review / investigation.Initial reporter is company representative.(b)(4).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 on (b)(6) 2018, the patient underwent a surgery with femoral neck system (fns).After the surgery, excessive sliding of the implant was confirmed.On (b)(6) 2019, a revision was performed.In the reoperation, the locking screw could not be rotated at all with a driver and the screw head became worn.The surgeon removed the screw by using a carbide drill.It took time to remove iron powder generated from the screw and to clean the surrounding areas, which caused an extra bleeding.Draping did not help in reducing iron powder because the screw cut was done in the deep position of the bone.The surgery was delayed by 60 minutes.The patient vomited post-operatively because she felt ill which may have been due to the prolonged operation time.This is report 1 of 2 for (b)(4).This complaint is related to (b)(4) which reports the excessive sliding after the initial surgery on (b)(6) 2018.This complaint is about the locking screw which could not be removed easily.
 
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
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2018, the patient underwent a surgery with femoral neck system (fns).After the surgery, excessive sliding of the implant was confirmed.On (b)(6) 2019, a revision was performed.In the reoperation, the locking screw could not be rotated at all with a driver and the screw head became worn.Surgeon initially used a short driver to turn and remove the screw, but couldn't.The surgeon attached the screwdriver bit to the t-handle, and \attached the inserter to the plate.The surgeon tried to turn the screw, but the screwdriver slipped, and the screw could not be rotated at all.The surgeon tried to turn it by using another screwdriver, but the screw head was worn, and it was deformed.The surgeon then removed the screw by using a carbide drill.It took time to remove iron powder generated from the screw and to clean the surrounding areas, which caused an extra bleeding.Draping did not help in reducing iron powder because the screw cut was done in the deep position of the bone.The bleeding could be stopped with gauze.There is no blood transfusion.The patient felt ill and vomited post-operatively, this was could have been due to the prolonged operation time.There was no extension of the hospital stay associated with vomiting.There were no pieces by carbide drill in the patient.The doctor confirmed by x-rays.Scheduled time of the re-operation was about 2 hours.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity 1).Unknown inserter (part # unknown, lot # unknown, quantity 1).Unknown handle (part # unknown, lot # unknown, quantity 1).This is report 1 of 2 for (b)(4).This complaint is related to (b)(4) which reports the excessive sliding after the initial surgery on (b)(6) 2018.This complaint is about the locking screw which could not be removed easily.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: device history, part: 412.214s, lot: l760450, manufacturing site: selzach, supplier: frueh verpackungstechnik ag, release to warehouse date: 06.Feb.2018, expiry date: 01.Jan.2028.Device was first manufactured unsterile under the lot l740511 in mezzovico and sterilized afterwards.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 412.214 with lot l740511 were reviewed: a manufacturing record evaluation was performed for the unsterile 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.
 
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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 Key9065463
MDR Text Key162300322
Report Number8030965-2019-68302
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 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number412.214S
Device Lot NumberL760450
Was Device Available for Evaluation? No
Date Manufacturer Received11/07/2019
Patient Sequence Number1
Treatment
UNK - HANDLES: TRAUMA.; UNK - INSERTION INSTRUMENTS: TRAUMA.; UNK - SCREWDRIVERS.
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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