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	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).
Event or Problem Description
It was reported by affiliate via email with tacit qa #2/0 eth v5, using the tacit anchor breaks the suture.There was no harm to the patient or surgical delay reported.The device is available to be returned for evaluation.Additional information received from the affiliate reported this event was also reported by another j&j employee.Additional event details were reported by the affiliate and stated: "the event occurred during a procedure for the reconstruction of the ligament.The surgeon was passing a stitch with tacit quickanchor 2.0 mini anchor reference, 212036, and the anchor thread disassembled.The sales rep reported the suture could not be placed in the anchor.It was reported the case was completed by passing another mini anchor and it worked very well and did not affect the patient." the affiliate reported the device will not be returning for evaluation.
Additional 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.H10 additional narrative: investigation summary = > the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (3927718), and no non-conformances were identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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 lot number (3927718), and no non-conformances were identified.

• 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: 9954333
• Report Number: 1221934-2020-01143
• Device Sequence Number: 19530277
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 08/31/2021
• Device Model Number: 212036
• Device Catalogue Number: 212036
• Device Lot Number: 3927718
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 05/08/2020
• Patient Sequence Number: 1