MAUDE Adverse Event Report: DEPUY MITEK LLC US TACIT THREADER DOUBLE ENDED 2PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: mitek complaints received only a tiny fragment of the anchor for evaluation.This complaint can be confirmed.However, we cannot discern a root cause for this failure with the returned fragment of the anchor.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed one other complaint from the same facility for this lot that was released to distribution on september 4, 2012.At this point in time, no corrective action is required, and no further action is warranted.However, 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 from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The customer reported that during an endo eyebrow lift, the customer's tacit anchor broke in half while being inserted.Half of the anchor remained on the inserter, the other half is contained.The surgeon completed the procedure using another like device.There were no patient consequences.The surgeon was concerned since this is the second time this has happened and requested a new inserter be sent to them.

• Brand Name: TACIT THREADER DOUBLE ENDED 2PK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7793028
• Report Number: 1221934-2018-50935
• Device Sequence Number: 1350895
• Product Code: JDR
• UDI-Device Identifier: 20886705007681
• UDI-Public: 20886705007681
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K945203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2013

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: 07/01/2017
• Device Catalogue Number: 222220
• Device Lot Number: 3634823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2013
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1