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Model Number 3910-900-091
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
A statement in additional information received through e-mail states, "he actually stayed with me after the surgery and we tried to pass a piece of cloth, it passed it ok till we bend it a few times to make it "thicker" and the same problem occurred (the needle didn't go through the hole as it should, it passed outside of it without the suture. " this indicates enough tissue was grasped that the upper jaw was open to the point where it would not align with the designed path of the needle. The needle has to pass through the upper jaw in order to catch the suture. Where the upper jaw was open too wide from grasping additional tissue the suture was not captured. The suture passer is not designed to grasp this much tissue and the information received indicates the suture passer was being used in a manner other than the way it was designed to be used. This is a known failure mode addressed in the risk management file for this product and does not exceed the occurrence rates. Occurrence rates are monitored for trends.
Event Description
The needled could not go through the rotator's cuff muscle in 9 of 10 times it was used, the one that did pass through the muscle did not bring the suture with it. When they tried the champion suture passer outside the patient, it worked, but in the patient it did not. We changed the needle and the second one worked just fine. No harm was made to the patient, the surgery took 40 minutes longer. Country of event: (b)(6).
Manufacturer Narrative
Update: the needle was returned to coorstek on 8-21-2018. Review of the needle shows a normal bend which indicates it passed through the suture passer with no issues. The needle was loaded into a suture passer and then cycled. The needle cycled through the suture passer and passed through the upper jaw with no issues. The suture passer was then cycled through a simulated tissue sample of normal thickness and passed through the upper jaw with no issues. If excess tissue is grasped it can open the upper jaw to a point where the needle will not pass through the upper jaw. There were no issues found with the returned product.
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Manufacturer (Section D)
867 west 400 north
logan UT 84321
Manufacturer (Section G)
867 west 400 north
logan UT 84321
Manufacturer Contact
robert bates
867 west 400 north
logan, UT 84321
MDR Report Key7562933
MDR Text Key109899514
Report Number3004086872-2018-00003
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 06/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2020
Device Model Number3910-900-091
Device Lot Number1432789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial