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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 135 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE; PLATE, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 135 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.224.222S
Device Problem Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 10/08/2019
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes 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 the (b)(6) as follows: it was reported that a dhs screw did not fit in the dhs plate after handling it correctly.No patient consequence.This is 2 of 2 for report (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.Device is not distributed in the united states, but is similar to device marketed in the usa.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.Investigation site: cq zuchwil, selected flow: device interaction ¿ unable to assemble.Visual inspection: the received lcp dhs-plate 135° was found in good condition.A visual inspection was performed, and no damage could be detected.Functional test: function test was performed with a corresponding demo dhs/dcs screw and did not show any abnormalities, the proper function is ensured.Investigation performed within pi-(b)(4) confirmed that the complained malfunction is a result of the deformation at the dhs/dcs screw.Document/specification review: the returned lcp dhs-plate was manufactured in december 2018 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformity noted.Summary:.The complained malfunction is not related to the lcp dhs-plate, therefore the complaint is unconfirmed for the plate.A function test was performed with a corresponding demo dhs/dcs screw and did not show any abnormalities, the proper function of the lcp dhs-plate is ensured.The manufacturing documents were reviewed and no complaint related issues were found.The relevant dimensions were checked and no deviation was found.No product related issue could be detected.The complained malfunction was clearly caused by the deformation at the dhs/dcs screw.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed (pictures attached within pi-(b)(4)).Device history lot part: 02.224.222s, lot: 2l15194, manufacturing site: grenchen, release to warehouse date: dec 04, 2018, expiry date: nov 01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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
135 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9256807
MDR Text Key195934094
Report Number8030965-2019-69829
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819818842
UDI-Public(01)07611819818842
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 10/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02.224.222S
Device Lot Number2L15194
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Date Manufacturer Received11/08/2019
Patient Sequence Number1
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