MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRIFXQA+ W/#4OC P3; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number: (b)(6).Investigation summary: the complaint device was received and evaluated.Visual observation reveals that the anchor, inserter, and the suture bridge is missing.Under magnification, the distal tip of the anchor revealed no structural anomalies.The reported condition can be confirmed.A root cause could not be definitively determined as the product was received missing certain components.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.Based on the complaint history, no further corrective action is warranted at this time.However, this file will remain receptive to any potential forthcoming information that is pertinent to this issue.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).The expiration date is unknown.
Event or Problem Description
At the moment to place the anchor, the anchor was broken during a hand procedure.Additional information was received via email from the affiliate on 2-24-16.The anchor did break during the insertion.The anchor was replaced for other to complete the procedure the original bone hole used to complete the procedure.The surgery did not extend 30 minutes.

• Brand Name: MICRIFXQA+ W/#4OC P3
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8318934
• Report Number: 1221934-2018-51256
• Device Sequence Number: 11178389
• Product Code: MAI
• UDI-Device Identifier: 10886705001897
• UDI-Public: 10886705001897
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2016

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 Catalogue Number: 212044
• Device Lot Number: 3839743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2016
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1