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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH BUTTRESS/COMPRESSION NUT FOR 357.369 APPARATUS, TRACTION, NON-POWERED

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SYNTHES 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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a synthes employee. 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. 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 (b)(6) reports an event as follows: it was reported that patient underwent a proximal femur osteosynthesis procedure on (b)(6) 2021, using the trochanteric femoral nail (tfn) system. At the time of the placement of the guide sheath for the spiral blade, it was not possible to fully face (finish); this happened because ¿the material that helps for this guide to fit correctly, when it reached the next third of said guide, it did not continue screwing,¿ (it remained stuck) and a maximum lever effort had to be made so that it could be brought closer. But it came to a point where the surgical team could no longer screw; leaving this guide separated from the cortex and giving a not so exact measurement of the spiral blade to be placed. The surgeon made an estimate on this measurement, since there was no other instrument that could replace this guide at that moment. The spiral sheet to be placed was chosen, and it was inserted leaving a suitable length. The procedure terminated with no greater impact to the patient. This report is for a buttress/compression nut. This is report 2 of 2 for (b)(4).
 
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Brand NameBUTTRESS/COMPRESSION NUT FOR 357.369
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SALZBURG
vorgartenstrasse 206b
wien 1020
AU 1020
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12760605
MDR Text Key284872476
Report Number8030965-2021-09339
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number357.371
Device Lot NumberH350057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/07/2021 Patient Sequence Number: 1
Treatment
BLD GUIDE SLEEVE FOR TFN
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