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

Model Number	212036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported by affiliate via email that during the procedure the suture and anchor were broken.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.
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.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.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that mini-anchors surgery was performed.
Additional 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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary = > according to the information provided, it was reported that during the procedure the suture and anchor were broken.The complaint device was received and evaluated.The anchor was reviewed under magnification, the anchor revealed no structural anomalies, besides the suture was found frayed or cuted.In addition, the handle and the thread drill also were received, as result the handle was found broken.This complaint can be confirmed.The possible root cause for the detached anchor can be attributed to the low tension applied in the suture for ruptured suture can be attributed to excessive force while inserting the anchor beyond its intended use causing it to bend and suture to snap.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [2l06363] number, 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.Udi: (b)(4).
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.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.H10 additional narrative: d10, h3, h6: 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.

• 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: 9747887
• Report Number: 1221934-2020-00670
• Device Sequence Number: 16597961
• Product Code: MBI
• UDI-Device Identifier: 10886705001842
• UDI-Public: 10886705001842
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K961094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2020

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: 10/31/2023
• Device Model Number: 212036
• Device Catalogue Number: 212036
• Device Lot Number: 2L06363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/06/2020; 04/07/2020; 04/29/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/06/2020; 04/08/2020; 04/30/2020
• Patient Sequence Number: 1
• Patient Weight: 82