• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

  • 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
 

SYNTHES GMBH BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Model Number 04.168.280S
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/06/2022
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2022 the revision of femoral neck system due to cut through.The surgery was completed without a surgical delay.Some fragments was generated.Patient status/ outcome: unknown this report is for one (1)bolt for femoral neck sys 80 length-sile.This is report 2 of 4 for complaint (b)(4).
 
Manufacturer Narrative
Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j sales representative.(b)(4).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.
 
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
BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen CO 2540
SZ   2540
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15491671
MDR Text Key300647029
Report Number8030965-2022-07397
Device Sequence Number1
Product Code KTT
UDI-Device Identifier10886982274724
UDI-Public(01)10886982274724
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172872
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number04.168.280S
Device Catalogue Number04.168.280S
Device Lot Number395P909
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/06/2022
Initial Date FDA Received09/27/2022
Supplement Dates Manufacturer Received10/04/2022
Supplement Dates FDA Received10/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
5.0 TI LCKNG SCR SLF-TPNG T25 SD 36-SILE; ANTIROTATION SCR FEM NECK 85 LNTH -S; FEMORAL NECK SYSTEM PL 1 HOLE - STERILE
Patient Outcome(s) Required Intervention;
Patient Age88 YR
Patient SexFemale
-
-