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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH HELICAL BLADE INSERTER; ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH HELICAL BLADE INSERTER; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.024
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, the spiral blade was jammed, and no longer detached.The surgery was completed successfully with 30 minutes delay.There was no patient consequence.This complaint involves two (2) devices.This report is for (1) helical blade inserter.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A product investigation was conducted.Visual inspection: the received tfna helical-blade impact is in an almost brand-new good condition.Functional test: a functional test was performed with the returned damaged connecscr f/tfna helic blade+scr and has shown that it is not possible to assemble adequately the tfna helical-blade impact in question as the thread of connecscrew is damaged.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.Summary: the complaint is rated as unconfirmed for this tfna helical-blade impact because that there is no allegation against of this device.A functional test was performed with the returned damaged connecscr f/tfna helic blade+scr and has shown that it is not possible to assemble adequately the tfna helical-blade impact in question as the thread of connecscrew is damaged.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.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are 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.A device history record (dhr) review was conducted: part number: 03.037.024.Lot number: t173029.Manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2019.A review of the device history records 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.
 
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Brand Name
HELICAL BLADE INSERTER
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10878485
MDR Text Key217713288
Report Number8030965-2020-09127
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819642508
UDI-Public(01)07611819642508
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.037.024
Device Lot NumberT173029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CONNECSCR F/TFNA HELIC BLADE+SCR
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