MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #3/0 OC V4; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 212843

Device Problem Failure to Advance (2524)

Patient Problem Not Applicable (3189)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Investigation summary: despite multiple attempts made to the affiliate for the return of the complaint device, the device has not been received for evaluation.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.No nonconformances were identified for this part number, serial number combination.Review conducted per qlik query executed on 7/9/2019.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.At this point in time, no corrective action is required, and 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).

Event Description

It was reported by the affiliate that the customer reported that the micro qa+ #3/0 oc v4 did not perform as expected.Additional information received from the affiliate reported the event occurred pre-op on (b)(6) 2019.It was also reported that the anchors did not hook appropriately which caused a surgical delay of an unknown amount of time.The affiliate reported the procedure was completed with other anchors.

• Brand Name: MICRO QA+ #3/0 OC V4
• Type of Device: SOFT-TISSUE ANCHOR, NON-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 ; 6103142063
• MDR Report Key: 8776749
• MDR Text Key: 150598875
• Report Number: 1221934-2019-57587
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705002375
• UDI-Public: 10886705002375
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 212843
• Device Lot Number: 2L06492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1