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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CINCHLOCK FLEX ANCHOR WITH INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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STRYKER ENDOSCOPY-SAN JOSE CINCHLOCK FLEX ANCHOR WITH INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number CAT02643
Device Problems Break (1069); Sticking (1597)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/31/2016
Event Type  Injury  
Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
 
Event Description
It was reported that when the surgeon went to cut the suture, the pull wire had broken proximally and was sticking through the cannula.There was a 20 minute delay as surgeon tried to remove wire by pulling on it.Wire broke and surgeon left wire flush with anchor.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: pull wire stuck in anchor probable root cause: design: poor mechanical advantage of locking feature.Materials of inserter locking mechanism cannot withstand user locking forces.Manufacturing: locking mechanism not manufactured or assembled to specification.Incorrect heat treatment applied.Application: not enough force applied.User unfamiliarity with device.(b)(4).
 
Event Description
It was reported that when the surgeon went to cut the suture, the pull wire had broken proximally and was sticking through the cannula.There was a 20 minute delay as surgeon tried to remove wire by pulling on it.Wire broke and surgeon left wire flush with anchor.
 
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Brand Name
CINCHLOCK FLEX ANCHOR WITH INSERTER
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
kimberly lynch
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key5595512
MDR Text Key43277167
Report Number0002936485-2016-00392
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCAT02643
Device Lot Number16011301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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