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

Model Number	212236
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate that during an unknown procedure after drilling with the accompanying drill bit, when the surgeon used, the thread of the tacit qa #2/0eth v5 was detached from the anchor body.No patient consequence and no surgical delay was reported.No additional information was provided.Additional information received from the affiliate reported the device will not be returning 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.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.
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.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 after drilling with the accompanying drill bit, when the surgeon used it, the thread of the anchor was detached from the anchor body.The complaint device was received and evaluated.Visual observations confirm that were received the anchor, the thread, the handle and the thread drill.In addition was observed the anchor was separated from the handle, tacit quickanchor.Under magnification, the anchor revealed no structural anomalies.In addition, the thread was still intact and was not frayed or cut.This complaint can be confirmed.The possible root cause can be attributed to the low tension applied in the thread, also can be attributed to user technique error.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [3l82056] 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.Device history lot = > a manufacturing record evaluation was performed for the finished device [3l82056] number, and no non-conformances were identified.

• Brand Name: TACIT QA #2/0ETH 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: 9777185
• Report Number: 1221934-2020-00717
• Device Sequence Number: 2204616
• Product Code: MBI
• UDI-Device Identifier: 10886705002023
• UDI-Public: 10886705002023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2020

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: 02/29/2024
• Device Model Number: 212236
• Device Catalogue Number: 212236
• Device Lot Number: 3L82056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/24/2020; 03/30/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/25/2020; 03/31/2020
• Patient Sequence Number: 1