MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ #2/O OCORD V-5; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 212035

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter phone number: (b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via email that during an opponensplasty the surgeon drilled correctly into good quality bone and put a mini qa+ #2/o ocord v-5 anchor in and it pulled out.The surgeon tried again and the anchor pulled out again.They had to use a second anchor and had nil issues with hold or with adverse patient outcome.A delayed surgical time of 2-3 mins was reported.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (6l65828), and no non-conformances were identified.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.

• Brand Name: MINI QA+ #2/O OCORD V-5
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10317758
• MDR Text Key: 200803437
• Report Number: 1221934-2020-01889
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001835
• UDI-Public: 10886705001835
• Combination Product (y/n): N
• PMA/PMN Number: K071257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 212035
• Device Catalogue Number: 212035
• Device Lot Number: 6L65828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Patient Sequence Number: 1