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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CINCHLOCK SS KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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STRYKER ENDOSCOPY-SAN JOSE CINCHLOCK SS KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number CAT02462
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2016
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was reported that the doctor implanted the cinchlock ss anchor successfully and then pulled the handle to remove the device.The pull wire was still engaged and stuck in the anchor.This occured during a hip arthroscopy, labral repair.There was no difference in resistance to remove the handle than during other uses of cinchlock ss.The surgeon had to use a suture cutter to cut the pull wire down flush with the anchor.The surgeon was unable to get the pull wire flush with the anchor so attempted a second time with the suture cutter.The surgeon was able to hold with a grasper to not lose the metal piece, and successfully cut the pull wire flush with the anchor.The metal fragment was removed successfully but the most distal portion of the pull wire remained in the anchor and caused a 10 min delay.No injury to the user or patient were reported.The procedure was completed successfully.
 
Manufacturer Narrative
(b)(4).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.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that the doctor implanted the cinchlock ss anchor successfully and then pulled the handle to remove the device.The pull wire was still engaged and stuck in the anchor.This occured during a hip arthroscopy, labral repair.There was no difference in resistance to remove the handle than during other uses of cinchlock ss.The surgeon had to use a suture cutter to cut the pull wire down flush with the anchor.The surgeon was unable to get the pull wire flush with the anchor so attempted a second time with the suture cutter.The surgeon was able to hold with a grasper to not lose the metal piece, and successfully cut the pull wire flush with the anchor.The metal fragment was removed successfully but the most distal portion of the pull wire remained in the anchor and caused a 10 min delay.No injury to the user or patient were reported.The procedure was completed successfully.
 
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Brand Name
CINCHLOCK SS KNOTLESS ANCHOR
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 Key5565381
MDR Text Key42311043
Report Number0002936485-2016-00348
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131769
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 03/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCAT02462
Device Lot Number16012501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2016
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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