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

Catalog Number 212035

Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4)¿ incomplete.The expiration date is not currently available.

Event Description

It was reported that the anchors did not deploy.Patient consequence? no.Action taken for procedure: opened additional anchors.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Investigation summary - the complaint device was discarded by the customer therefore the device is not available for a physical evaluation.This complaint is not confirmed.It was reported that implant pulled out after insertion.No further procedure information or user technique was provided to determine if the above reason contributed to this failure.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a review into the depuy mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.At this point in time, no corrective action is required, and no further action is warranted.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.Udi:(b)(4).Associated medwatch: 1221934-2018-51114.

Event Description

It was reported that the anchors did not deploy.Patient consequence? :no.Action taken for procedure:opened additional anchors.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.Additional information from sales rep: spoke with the sales rep to obtain additional information and was told he was not present during this thumb procedure.He was informed that his mini q/a and micro quick anchors both pulled out.The doctor used another mini q/a anchor to complete the procedure.It is unknown what type of bone quality the patient had.

• Brand Name: MINI QA+ #2/O OCORD V-5
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7557096
• MDR Text Key: 109753628
• Report Number: 1221934-2018-51100
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 212035
• Device Lot Number: 3922510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1