Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.033.001
Device Problems Break (1069); No Apparent Adverse Event (3189)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a j&j employee.The device was 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 on an unknown date, the thread of the driving cap snapped off into the radiolucent insertion handle.This was found during loan kit inspection.There was no patient involvement.This report is for one (1) radiolucent insertion handle frn.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.H6: the initial complaint was reviewed and found not reportable.There was no complaint against the insertion handle.The complaint is against the driving cap which has been reported on medwatch report 8030965-2020-08894.The insertion handle is concomitant to the driving cap.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
The initial complaint was reviewed and found not reportable.There was no complaint against the insertion handle.The complaint is against the driving cap which has been reported on medwatch report 8030965-2020-08894.The insertion handle is concomitant to the driving cap.
 
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.Investigation summary investigation site: cq zuchwil, selected flow: 2.Device interaction/functional.Visual inspection: the received insert-handle has shown that the threaded tip of the driving cap stuck in the threaded connection hole.The surface of the connection section present wear marks.Apart from that the instrument shows signs of use.Functional test: a functional test can not be performed.The broken threaded tip is completely jammed / stuck in the threaded connection hole of the insert-handle.Therefore the instrument is not functionally as designed required anymore.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.Dimensional inspection: the threaded tip of the driving cap stuck in the threaded connection hole of the insert-handle.Therefore, no measurements of the features are possible.Summary: the complaint is rated as confirmed for this returned insert - handle because that there is not more functional as intended.The received insert-handle has shown that the threaded tip of the driving cap stuck in the threaded connection hole.The surface of the connection section present wear marks.Apart from that the instrument shows signs of use.Based on these findings we have to assume that there was a loose or insufficient connection between the insertion handle and driving cap which finally caused the post manufacturing damages.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part: 03.033.001, lot: l705288, manufacturing site: hägendorf, release to warehouse date: march 19, 2018.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RADIOLUCENT INSERTION HANDLE FRN
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10823899
MDR Text Key216621842
Report Number8030965-2020-08858
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07612334121776
UDI-Public(01)07612334121776
Combination Product (y/n)N
PMA/PMN Number
K172157
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 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.033.001
Device Lot NumberL705288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Date Manufacturer Received11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DRIVING CAP F/INSERTION HANDLE
-
-