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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 20MM; PLATE,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 20MM; PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.200.020TS
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2020
Event Type  malfunction  
Manufacturer Narrative
Additional device product code: hwc.Reporter is a j&j employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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 (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2020 it was identified that the inner part with the screw of the steril-tube got stuck in the outer part.There was no surgical delay.Procedure was not completed successfully.No patient consequences reported.This report is for one (1) 3.5mm ti stardrive cortex screw self-tapping 20mm.This is report 1 of 7 for (b)(4).This complaint is linked to (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.H4, h6: a device history record (dhr) review was conducted: part: 04.200.020ts, lot: 6l35320, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 28.Oct.2019, expiry date: 01.Oct.2024.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.
 
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.H3, h4, h6: the cortex screw was received with the reported condition that the inner tube did not disengage from outer tube.The inspection performed at cq zuchwil confirmed that after unscrewing the outer cap the entire inner tube (cap with holder and screw) is retained within the outer tube, preventing the screw from being removed and used.No further damage is visible.The complaint condition is confirmed as the inner tube is retained within the outer tube during disassembly preventing the screw from being removed and used.This production lot: 6l35630 was manufactured in october 2019 according to the specification.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Further investigation has shown that this production lot is part of the corrective and preventive action (capa) and part of the field safety notice fsn.The root cause was identified during the performed capa evaluation (inadequately defined design of the inner tube & inner cap).All further investigations and actions will be documented within capa and hence the in the investigation flow listed remaining investigation steps are not required.Device history: lot part: 04.200.020ts, lot: 6l35630, manufacturing site: selzach, supplier: früh verpackungstechnik ag, release to warehouse date: 28.Oct.2019, expiry date: 01.Oct.2024.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.
 
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Brand Name
3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 20MM
Type of Device
PLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10309782
MDR Text Key199922232
Report Number8030965-2020-05157
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K131186
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 07/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.200.020TS
Device Lot Number6L35320
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2020
Date Manufacturer Received09/23/2020
Patient Sequence Number1
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