• 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 DPS HAERTOE CCI LRG KIT 1.60 K-WIRE/ S; STAPLE, FIXATION, BONE

  • 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 DPS HAERTOE CCI LRG KIT 1.60 K-WIRE/ S; STAPLE, FIXATION, BONE Back to Search Results
Catalog Number 46.239.002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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
It was reported that on (b)(6) 2023, several patients had difficulty healing incision wounds.One patient experienced the implant backing out.The implant in question is hammertoe cci.The patient required a revision surgery.It was notified about multiple incidents in one conversation.There wasn't dialogue about number of patients, but it was stated that it was several.The implant was hammertoe cci in both sizes.This report is for one (1) dps haertoe cci lrg kit 1.60 k-wire/ s this is report 2 of 2 for complaint (b)(4).This report captures the reported several patients, while related complaint pc-001485735 captures the one patient who experienced the implant backing out.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DPS HAERTOE CCI LRG KIT 1.60 K-WIRE/ S
Type of Device
STAPLE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key18377629
MDR Text Key331140693
Report Number8030965-2023-16057
Device Sequence Number1
Product Code JDR
UDI-Device Identifier00810633022054
UDI-Public(01)00810633022054
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191463
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
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? No
Device Operator Health Professional
Device Catalogue Number46.239.002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2023
Initial Date FDA Received12/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S
Patient Outcome(s) Required Intervention;
-
-