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 DHS/DCS LAG SCREW 12.7MM THREAD/100MM-STERILE; APPLIANCE,FIXATION,NAIL
  • 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 DHS/DCS LAG SCREW 12.7MM THREAD/100MM-STERILE; APPLIANCE,FIXATION,NAIL Back to Search Results
Catalog Number 280.000S
Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)
Patient Problems Failure of Implant (1924); Blood Loss (2597); No Code Available (3191)
Event Date 07/06/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.(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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during a surgery for a femoral neck fracture the surgeon had difficulty adapting the hs 130° plates 2 holes and 4 holes onto the cephalic screw of 10 mm in length.It seemed the diameter of the cephalic screw is slightly larger than the diameter of the dhs plate conduit.Another plate 135°, which was not adapted was used.There was sixty (60) minute surgical delay.Medical intervention for bleeding was needed.The procedure was completed successfully.There was a reported septic risk during the procedure to the patient.Concomitant devices reported: lcp dhs-pl 130° 2ho l60 standbarrel sst (part number 02.224.202s, lot l837247, quantity 1), lcp dhs-pl 130° 4ho l92 standbarrel sst (part number 02.224.204s, lot l923242, quantity 1).This report involves one (1) dhs®/dcs® lag screw 12.7mm thread/100mm-sterile.This is report 3 of 3 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.H3, h6: part: 280.000s, lot: 4l20926, manufacturing site: balsthal, release to warehouse date: april 12, 2019, expiry date: april 01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection has shown that the positioning groove of the dhs/dcs screw is expanded and damaged.There are clearly visible impression marks form the wrench in the groove as well as some dents at the shaft surface.Otherwise, the screw is in a good condition.Dimensional inspection: document/drawing: feature/test/description: shaft outer diameter (near damage area) results "pass" feature/test/description: shaft 2-kt sw 7.15 (near damage area) results "pass the measured dimensions were found to be within the given specifications per the drawings referenced above.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.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength, and structural stability.The values were in compliance with ao/asif specification and with the international standard iso 5832-1 for implants for surgery, stainless steel.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Investigation conclusion: the returned dhs/dcs blade was examined and the complaint condition was able to be confirmed.The positioning groove of the dhs/dcs screw is expanded and damaged.There are clearly visible impression marks form the wrench in the groove as well as some dents at the shaft surface.The investigation has shown that the deformation at the groove of the blade is responsible and therefore the dhs plate could not be slide on the dhs/dcs blade shaft.The exact cause of the damage cannot be defined as there was just few information provided.Based on the information we received, we can only assume that the connecting screw for insertion of dhs blade is not tight screwed in the blade during insertion which lead to the damage of the blade shaft.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 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: 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DHS/DCS LAG SCREW 12.7MM THREAD/100MM-STERILE
Type of Device
APPLIANCE,FIXATION,NAIL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10312136
MDR Text Key200012968
Report Number8030965-2020-05189
Device Sequence Number1
Product Code KTT
UDI-Device Identifier07611819055278
UDI-Public(01)07611819055278
Combination Product (y/n)N
PMA/PMN Number
K791619
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 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number280.000S
Device Lot Number4L20926
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Date Manufacturer Received09/01/2020
Patient Sequence Number1
Treatment
LCP DHS-PL 130° 2HO L60 STANDBARREL SST; LCP DHS-PL 130° 4HO L92 STANDBARREL SST; LCP DHS-PL 130° 2HO L60 STANDBARREL SST; LCP DHS-PL 130° 4HO L92 STANDBARREL SST
Patient Outcome(s) Required Intervention;
-
-