MAUDE Adverse Event Report: DEPUY MITEK LLC US MICROFIX QA+#3/0 OC V-4W/BIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 212859

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device is not being returned, therefore is unavailable for a physical evaluation.A review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.Multiple emails have been sent to gather additional information on the product complaint, but no updates have been received.At this point in time, no corrective action is required and no further action is warranted.A non-conformance search was performed for this product code 212859-lot #3860194 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the affiliate in france that the microfix qa+#3/0 oc v-4w/bit anchor device did not fix into the bone as it pulled out.According to the reporter, the event occurred while the anchor is being inserted and it did not fix.It was further reported that the anchor was retrieved.Ix to bone (pullout).When introducing the anchor, the anchor did not fix.The anchor was retrieved.There was no delay in the surgical procedure as an identical spare device was used to complete the 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: MICROFIX QA+#3/0 OC V-4W/BIT
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8278400
• MDR Text Key: 134879422
• Report Number: 1221934-2018-53845
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705002481
• UDI-Public: 10886705002481
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 212859
• Device Lot Number: 3860194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1