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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
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.Udi: (b)(4).Investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part and lot combination and no non-conformance's were identified.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.Depuy 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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep in (b)(6) that during an unspecified surgical procedure, it was observed that upon opening from its sealed packaging, the anchor tacit 2.0 was in bad condition with its broken tip and the product could not be used in surgery and a new unit had to be opened.It was not reported if there was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: 9103792
• Report Number: 1221934-2019-58432
• Device Sequence Number: 11349569
• Product Code: MBI
• UDI-Device Identifier: 10886705001842
• UDI-Public: 10886705001842
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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: 04/30/2021
• Device Catalogue Number: 212036
• Device Lot Number: 3908429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1