MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX PEEK ANCH.W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2013
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 devices were not available for evaluation as they were left inside the patient.Therefore, this complaint cannot be confirmed.However, 3 new unopened devices were returned to mitek complaints and were evaluated.Visual observation under magnification revealed no anomalies on the 3 anchors and suture.These anchors were deployed and knots tied down using the sutures without any issues.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 a non-conformance was opened relating to deals with an aesthetical problem on the orthocord sutures with no functional impact on the tensile strength of sutures, with no link with this complaint.A non-conformance was opened relating to deals with the delay in time exposure of sutures.All sutures of these batches were removed by conform ones - no functional impact on the finished products, and no link to this complaint.Further, a review into the mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.We cannot discern a root cause for this failure.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 (b)(4) 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 two sutures for two of the customer's healix peek 5.5mm anchors broke while trying to tie sutures during a rotator cuff procedure.The sales representative stated the surgeon was able to use the other sutures to tie down the anchors with no patient consequences or delays.There was nothing broken left inside the patient.The customer requested replacements of all the anchors left on his shelf of this lot.The sales representative is returning all the anchors on the shelf for evaluation.The sales representative stated it was good bone and had no patient information to provide.Please see also medwatch report 1221934-2018-50975.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated evaluation statement: the complaint devices were not available for evaluation as they were left inside the patient.Therefore, this complaint cannot be confirmed.However, three (3) new unopened devices were returned to mitek complaints and were evaluated.Visual observation under magnification revealed no anomalies on the 3 anchors and suture.These anchors were deployed and knots tied down using the sutures without any issues.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 a non-conformance was opened relating to deals with an aesthetical problem on the orthocord sutures with no functional impact on the tensile strength of sutures, with no link with this complaint.A non-conformance was opened relating to deals with the delay in time exposure of sutures.All sutures of these batches were removed by conform ones - no functional impact on the finished products, and no link to this complaint.Further, a review into the mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.We cannot discern a root cause for this failure.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).Associated medwatch report number: 1221934-2018-50975.

• Brand Name: 5.5 HEALIX PEEK ANCH.W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8024361
• Report Number: 1221934-2018-50974
• Device Sequence Number: 1484280
• Product Code: MAI
• UDI-Device Identifier: 10886705007578
• UDI-Public: 10886705007578
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• 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,Followup
• Report Date (Section B): 06/05/2013

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: 222209
• Device Lot Number: 3670603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2013
• Initial Date Received by Manufacturer: 06/05/2013
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3 HEALIX PEEK 5.5MM ANCHORS; 3 HEALIX PEEK 5.5MM ANCHORS