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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: LOCKING; SCREW, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: LOCKING; SCREW, FIXATION, BONE Back to Search Results
Catalog Number UNK - SCREWS: LOCKING: TRAUMA
Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).This report is for an unknown screws: locking/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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 the: implant placed on the site not indicated: surgery of the proximal tibia system, where they requested remission of the proximal tibia system 3.5 av, a surgical procedure begins, where the specialist indicates that he wishes to put a distal radius plate and 1/3 cane plate since the requested system plate was very large, in addition, the distal radius plate is for a 2.4 / 2.7 system and dr.Decides to put a 3.5 screw on the branch since the indicated ones were very short.Surgery was delayed due to the reported events 20 minutes and there were no fragments generated.Device is still implanted in the patient.Concomitant device reported: unknown distal radius plate (part # unknown, lot # unknown, quantity unknown), unknown 1/3 cane plate (part # unknown, lot # unknown, quantity unknown), unknown locking screws (part # unknown, lot # unknown, quantity unknown).This complaint involves an unknown number of devices.This report is for one (1) unk - screws: locking.This report is 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.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
This report is 1 of 2 for (b)(4).
 
Event Description
The patient´s bone structure was too small for the proximal tibia system.Screws from another system were placed to complete the procedure.Only two plates were implanted.
 
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.
 
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Brand Name
UNK - SCREWS: LOCKING
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9715386
MDR Text Key191454207
Report Number8030965-2020-01164
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
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 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK - SCREWS: LOCKING: TRAUMA
Was Device Available for Evaluation? No
Date Manufacturer Received03/05/2020
Patient Sequence Number1
Treatment
UNK - PLATES; UNK - PLATES; UNK - SCREWS: LOCKING
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