MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK 3SUT W/OC; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222307
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint product was received and tested.The returned sample of violet orthocord suture was tested for tensile strength.During the testing, the results were within the acceptable standards.Design specifications for straight break test states that it must be a minimum of 46.8 lbs and the results of the sample was 50.21 lbs.Design specifications for knot break test states that the tensile strength must be a minimum of 24.0 lbs and the results of the sample was 24.83 lbs, passing the test.We cannot discern a root cause for this failure mode.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.No nonconformances were identified for this part-lot number combination per qlik query executed 11/12/2018.Review conducted per nr-0108348.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair two out of the three sutures broke in a case, not sure if an issue with the orthocord, or the expresses gun.One suture remained and the repair was completed.Only a 10 minute delay to surgery.No adverse event.

• Brand Name: 5.5 HEALIX ADVANCE PEEK 3SUT W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8286987
• Report Number: 1221934-2019-56239
• Device Sequence Number: 11438455
• Product Code: HWC
• UDI-Device Identifier: 10886705021420
• UDI-Public: 10886705021420
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 222307
• Device Lot Number: 3896819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2016
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1