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 BUTTRESS/COMPRESSION NUT FOR 357.369; APPARATUS, TRACTION, NON-POWERED
  • 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 BUTTRESS/COMPRESSION NUT FOR 357.369; APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 357.371
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) 2020, during a proximal femur osteosynthesis using an intertrochanteric nail, at the time of placing the spiral blade, the surgeon used the hammer for impactions which caused the head of the connecting screw to break.The surgeon was unable to remove the screw from the blade and decided to remove the blade again by hitting the insertion arc.The blade was removed and the procedure was continued.The arch wire was already damaged by the impactions.The drill guide was placed for the distal locking of the nail, and this hole through which the drill guide sleeve passes is not in good condition.The sleeve entered the hole and the drilling was made for the distal locking of the nail.The procedure was completed successfully.No patient consequence reported.Concomitant devices reported: unknown tfn nail (part # unknown, lot # unknown, quantity 1), unknown hammer (part # unknown lot # unknown, quantity 1), unknown tfn helical blade (part # unknown, lot # unknown, quantity unknown), unknown hammer (part # unknown, lot # unknown, quantity unknown).This report is for one (1) buttress/ compression nut for 357.369.This is report 3 of 6 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BUTTRESS/COMPRESSION NUT FOR 357.369
Type of Device
APPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10818077
MDR Text Key217103326
Report Number8030965-2020-08811
Device Sequence Number1
Product Code HST
UDI-Device Identifier07611819737570
UDI-Public(01)07611819737570
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number357.371
Was Device Available for Evaluation? No
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AIM-ARM F/TFN 130°; CONNECSCR F/HELICAL BLADE F/TFN; GUIDE SLEEVE F/HELICAL BLADE F/TFN; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE; UNK - NAILS: TFN
-
-