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

Catalog Number CAT02462

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2016

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 during hip arthroscopy labral repair, the doctor successfully implanted cinchlock ss anchor.When the doctor pulled handle to deploy cinchlock and as pulled out pull wire was still engaged and stuck in anchor; there was no difference in resistance to remove the handle than during other uses of cinchlock ss.The doctor used a suture cutter to cut the pull wire flush with the anchor.This resulted in an extra 10 minutes to the case.No injury to user or patient.Two implants were opened at the beginning of the case, but only the anchor reported in this event was used.

Manufacturer Narrative

(b)(4).The device manufacture date is not known device was not returned for evaluation to confirm lot number.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 during hip arthroscopy labral repair, the doctor successfully implanted cinchlock ss anchor.When the doctor pulled handle to deploy cinchlock and as pulled out pull wire was still engaged and stuck in anchor; there was no difference in resistance to remove the handle than during other uses of cinchlock ss.The doctor used a suture cutter to cut the pull wire flush with the anchor.This resulted in an extra 10 minutes to the case.No injury to user or patient.Two implants were opened at the beginning of the case, but only the anchor reported in this event was used.

• 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: 5542664
• MDR Text Key: 41719191
• Report Number: 0002936485-2016-00311
• 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: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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