MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX TRANSTEND (BR/1) DS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222337
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2014
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 devices were received and evaluated.Visual observation reveals that the received anchor is broken transversally along the cancellous threads.This complaint can be confirmed.Anchor breakages are typically associated with off axis insertion, levering during insertion, or using incorrect instrumentation for preparing bone hole.The ifu instructs using an awl-tap for this anchor.Using only an awl in a good/ hard bone could lead to an increased risk of anchor breakage while inserting.It was reported that the user used healix awl/tap, and that the bone quality was hard.A batch review was conducted to determine if there were any internal processing issues, which would have contributed to the nature of the product complaint.Our results indicate that this batch was processed with one unrelated incident relating to a labelling issue, with no link with this complaint.Therefore, there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed one other similar complaint and one other dissimilar complaint for this lot released to distribution.We cannot discern a root cause for this failure.Based on the overall complaint rate for this failure, at this point in time, no further action is warranted.However, 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.Udi: (b)(4).This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 2 of 2 for the same event.It was reported by the sales rep reported that during a rotator cuff repair that the customer's healix transtend br anchor dual suture broke midbody when it was about 1/2 way inserted into the bonehole.The surgeon removed the broken piece of anchor and left the implant securely contained within the bonehole.The surgeon then inserted a second healix transtend br anchor dual suture which would not engage fully into the bonehole.This anchor was left sitting proud.The surgeon used the cannula and mallet to break off the proud pieces until only 1mm of the anchor was left outside of the bone.The sales rep reported that the surgeon removed all broken pieces from the patient joint space.The surgeon completed the procedure with this second anchor with no patient consequences but there was a ten minute delay.The sales rep reported that the bonehole was prepped with the healix awl/tap and that the bone quality was hard.The sales rep was able to retrieve a broken piece of the anchor which will be sent in for evaluation.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: HEALIX TRANSTEND (BR/1) DS
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7840638
• Report Number: 1221934-2018-54389
• Device Sequence Number: 1271756
• Product Code: HWC
• UDI-Device Identifier: 10886705023844
• UDI-Public: 10886705023844
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 222337
• Device Lot Number: 3702560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2014
• Initial Report FDA Received Date: 09/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1