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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 RECESS 12MM; SCREW,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; SCREW,FIXATION,BONE Back to Search Results
Catalog Number 401.762S
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Additional device product codes: hrs.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Occupation: reporter is a synthes employee.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 an unknown date, that the customer received an empty package.The package should have included one (1) 2.4mm ti cortex screw slf-tpng with t8 stardrive recess 12mm.There was no patient involvement.This report involves one (1) 2.4mm ti cortex screw slf-tpng with t8 stardrive recess 12mm.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: correction: h4.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, h6: sterile-part part: 401.762s, lot: 6l61491, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: january 21, 2020, expiry date: january 01, 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile-part part: 401.762, lot: 35p1479, manufacturing site: grenchen, release to warehouse date: january 07, 2020.A manufacturing record evaluation was not performed since there is no allegation of the reported complaint condition.Product was not returned.Reviewing the provided picture, the package is empty.Further evaluation is possible when part is available for investigation.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.
 
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Brand Name
2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10127871
MDR Text Key194310459
Report Number8030965-2020-03981
Device Sequence Number1
Product Code HWC
UDI-Device Identifier07611819284180
UDI-Public(01)07611819284180
Combination Product (y/n)N
PMA/PMN Number
K112583
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 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number401.762S
Device Lot Number6L61491
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/27/2020
Initial Date FDA Received06/08/2020
Supplement Dates Manufacturer Received06/29/2020
07/15/2020
Supplement Dates FDA Received07/15/2020
07/27/2020
Patient Sequence Number1
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