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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE 14MM STERILE; PLATE,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE 14MM STERILE; PLATE,FIXATION,BONE Back to Search Results
Catalog Number 401.764TS
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional product code hwc.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient was treated for a secondary disassociated distal radius extension fracture due to fracture wasn't fixated as planned.It is unknown how the issue was discovered.It is unknown if there was a patient consequence.This complaint involves ten (10) devices.This report is for (1) 2.4mm ti cortex screw slf-tpng with t8 stardrive 14mm sterile.This is report 10 of 10 for (b)(4).Related product complaint: (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.H3, h4, h6: 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 history lot steriel part: part: 401.764ts, lot: 6l85228, manufacturing site:, supplier: (b)(4), release to warehouse date: 09.Apr.2020, expiry date: 01.Mar.2025.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non sterile part: 401.764, lot: 6l85228, manufacturing site: grenchen , release to warehouse date: 04 march 2020.A manufacturing record evaluation was performed for the part: 401.764, lot: 6l85228 , 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.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
Update: the initial surgery occurred on (b)(6) 2020.
 
Manufacturer Narrative
Product complaint # (b)(4).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.B4: alert date should be 8/13/2020, not 9/14/2020.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
Update: no additional revision surgery was performed due to the event.
 
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Brand Name
2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE 14MM STERILE
Type of Device
PLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10576939
MDR Text Key208351118
Report Number8030965-2020-07383
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07612334104441
UDI-Public(01)07612334104441
Combination Product (y/n)N
PMA/PMN Number
K953644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number401.764TS
Device Lot Number6L85228
Was Device Available for Evaluation? No
Date Manufacturer Received10/27/2020
Patient Sequence Number1
Treatment
CORTSCR Ø2.4 SELF-TAP L16 TAN; VA LOCKSCR Ø2.4 SELF-TAP L12 TAN; VA LOCKSCR Ø2.4 SELF-TAP L14 TAN; VA LOCKSCR Ø2.4 SELF-TAP L16 TAN; VA LOCKSCR Ø2.4 SELF-TAP L18 TAN; VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 3H
Patient Outcome(s) Required Intervention;
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