MAUDE Adverse Event Report: DEPUY MITEK LLC US TACIT QA #2/0 ETH V5; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212036
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number: (b)(6).Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.The inserter and suture lengths attached to the needles were received.The inserter was visually inspected to observe any visual anomalies present that may have contributed to the complaint condition, however none were observed.The needles were attached to two suture lengths of approximately the same length with the ends of each suture frayed, indicating that the suture was cut.Per the instructions for use (ifu), overloading the anchor or applying excessive tension to the suture once the anchor is deployed will cause the suture to break therefore is a potential root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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 or Problem Description
It was reported by the affiliate that the suture on the customer's tacit qa anchor and minilok qa anchor broke.
Additional 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.H11 corrected data: g4: date received by manufacturer for the initial report should be january 23, 2019.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.

• Brand Name: TACIT QA #2/0 ETH V5
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8281907
• Report Number: 1221934-2019-56157
• Device Sequence Number: 19159207
• Product Code: MBI
• UDI-Device Identifier: 10886705001842
• UDI-Public: 10886705001842
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K961094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 212036
• Device Lot Number: L436637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 10/24/2019
• Patient Sequence Number: 1