MAUDE Adverse Event Report: DEPUY MITEK 4.5 HEALIX ADVANCE W/PERMACORD PEEK 3 SUTURE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	223135
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2014
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.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 no other complaints of any kind for this lot 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.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
It was reported by the sales rep that during a rotator cuff repair surgical procedure, it was observed that the customer¿s healix advance (peek) 4.5mm anchor with permacord 3 suture pulled out.The surgeon completed the procedure with another same type, larger size 5.5mm anchor in the same bonehole.The sales rep reported that the bonehole was prepped with the awl and there was hole divergence when the surgeon reinserted the awl.The sales rep reported that the bone quality was softer than normal.It was not reported if there were any delays in the surgical procedure.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: 4.5 HEALIX ADVANCE W/PERMACORD PEEK 3 SUTURE
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7722382
• Report Number: 1221934-2018-52673
• Device Sequence Number: 1619170
• Product Code: MAI
• UDI-Device Identifier: 10886705024759
• UDI-Public: 10886705024759
• Combination Product (Y/N): N
• PMA/510(K) Number: K133794
• 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): 09/24/2014

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: 02/01/2017
• Device Catalogue Number: 223135
• Device Lot Number: 3759846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2014
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1