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

Catalog Number	222307
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2013
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.Evaluation statement : the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been 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 of product was processed with an unrelated non-conformance to the reported incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed 1 dis-similar complaint for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The sales representative reported that surgeon inserted 2 healix advance peek anchors to repair a rotator cuff tear.Anchors went in great.He passed all sutures without incident or noticeable damage to any of the sutures.He used linvatec spectrum and pds suture to shuttle all the sutures through the cuff.During knot tying, one strand of the blue suture broke on each anchor.Surgeon places a clamp (sometimes called a mosquito) on the suture to prevent the knot pusher from dropping on the floor if the suture slips from surgeon¿s hand during tying.Each suture broke right at the point where the mosquito grasper held the suture.This is outside the cannula, so the surgeon was able to complete the suture tying by re-grasping the broken suture at its new (shortened) end and continue the tying process.

• Brand Name: HEALIX ADVANCE PEEK ANCHOR, 5.5 MM W/ORTHOCORD - 3 SUTURE
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7677632
• Report Number: 1221934-2018-51095
• Device Sequence Number: 1528200
• Product Code: HWC
• UDI-Device Identifier: 10886705021420
• UDI-Public: 10886705021420
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120449
• 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): 07/19/2013

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: 02/29/2016
• Device Catalogue Number: 222307
• Device Lot Number: 3684386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2013
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1