MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CINCHLOCK SS KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number CAT02462

Device Problems Break (1069); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported upon removing the inserter the pull wire broke proximally outside of joint.The surgeon tried pulling wire to remove it but it was stuck within the anchor.There was a 1 minute delay to cut pull wire flush with anchor and remove.

Manufacturer Narrative

Alleged failure: pull wire broke.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 alleged failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported upon removing the inserter the pull wire broke proximally outside of joint.The surgeon tried pulling wire to remove it but it was stuck within the anchor.There was a 1 minute delay to cut pull wire flush with anchor and remove.

• 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 Key: 5609550
• MDR Text Key: 43698704
• Report Number: 0002936485-2016-00405
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAT02462
• Device Lot Number: 16012501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other