MAUDE Adverse Event Report: DEPUY MITEK MICRO QUICK ANCHOR W/ #4 ORTHOCORD & C-1 NEEDLES; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2015
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 device was received and evaluated.Visual observation reveals that the anchor is off the inserter but still intact and held in place by the suture.Under magnification, the anchor revealed no structural anomalies.The suture was still intact and was not frayed or cut.This failure cannot be confirmed.It was reported that the patient had hard bone.No further procedural details were provided that could determine a root cause for the reported failure.A batch record review has been conducted and the results indicate that this batch of product was processed with one unrelated incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaint of any kind for this lot of devices that were released to distribution.At this point in time, based on the complaint rates, 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.(b)(4).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
It was reported by the sales rep that during a rotator cuff procedure, it was observed that the micro quick anchor w/ #4 orthocord & c-1 anchor was broken, however, the sales rep stated the anchor looked intact.It was reported that the bone quality of the patient was very hard.It was also reported that the surgeon prepped the bonehole with the included drill.It was reported that the procedure was completed with another like device using the same hole.It was reported that there were no delays in the in the procedure.The sales rep was not present and had no further information.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: MICRO QUICK ANCHOR W/ #4 ORTHOCORD & C-1 NEEDLES
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7764407
• Report Number: 1221934-2018-54059
• Device Sequence Number: 13754185
• Product Code: HWC
• UDI-Device Identifier: 10886705001873
• UDI-Public: 10886705001873
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K080352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2015

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: 10/31/2017
• Device Catalogue Number: 212041
• Device Lot Number: 3810268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2015
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1