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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 Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported the anchor became stuck in the inserter.The inserter became compromised as the doctor attempted to impact the anchor in place which resulted in the inserter prematurely releasing the anchor before it had been placed at the appropriate depth.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: anchor became stuck in the inserter.Probable root cause: design: anchor/inserter too large to insert into cannula.Anchor/inserter has difficult sharp/geometry which impedes insertion.Manufacturing: anchor/inserter not manufactured to specification.Anchor/inserter not assembled to specification.Application: excessive force.Off angle insertion.The alleged failure mode will be monitored for future reoccurrence.Mfg date: (b)(6) 2016.(b)(4).
 
Event Description
It was reported the anchor became stuck in the inserter.The inserter became compromised as the doctor attempted to impact the anchor in place which resulted in the inserter prematurely releasing the anchor before it had been placed at the appropriate depth.
 
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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 Key5765527
MDR Text Key48667730
Report Number0002936485-2016-00608
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 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCAT02643
Device Lot Number16042801
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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