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

Catalog Number 212035

Device Problem Failure to Advance (2524)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 2 for the same event.It was reported by the customer via phone that during an trapeziectomy of the right wrist surgical procedure, it was observed that two of the customer's mini quickanchor+ with orthocord would not seat.The customer was not present and did not know if the case was completed successfully; however, it was reported that both devices were removed.It was reported that there was no difficulty aligning instruments required for insertion prior to use.It was reported that there was no excessive force needed to insert the device.It was reported that there were no alternatives readily available and sutures were used instead.There was no patient harm reported, but there was a surgical delay to open the new implants, but the customer could not state how long.One of the anchors was discarded, the availability of the second anchor is unknown.It was not reported if there was medical intervention or prolonged hospitalization.The status of the patient post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and inspected for the reported failure mode.The complaint cannot be confirmed.Visual inspection under magnification was performed to reveal any gross visual defects that may contribute to the complaint condition.However,no visual defects were observed.The anchor with orthocord was not sent with the device.Hence, the functional testing cannot be performed and root cause for the reported failure cannot be determined.A non-conformance search was performed and no non-conformances were identified for this part number (212035) with lot number (1l85545 ) combination per qlink search performed on (b)(6) 2019.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.Udi: (b)(4).

• 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: 8662507
• MDR Text Key: 146793116
• Report Number: 1221934-2019-57269
• 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: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 212035
• Device Lot Number: 1L85545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention