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

Catalog Number	212036
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2015
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.The complaint device was received and evaluated.Only the inserter with the suture and suture card were sent back, the anchor was not sent back for evaluation.There were no anomalies with the inserter that would have contributed to the reported failure.The ends of the returned sutures were frayed, indicating a probability that the user might have applied an excessive tension damaging the suture, and pulling out the anchor.No further procedural details were provided that could determine a root cause for the reported failure.A batch record review has been conducted and the 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 synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point, 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.(b)(4).This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported that during a lip procedure, at the moment that the physician was placing the anchor, the anchor did not stay in bone of the patient.When the physician was pulling the suture anchor for to check if the anchor was stable into patient´s bone, the anchor leaves the patient´s bone.The device was removed.

• Brand Name: TACIT QA #2/0 ETH V5+ HAND DRBT
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7753978
• Report Number: 1221934-2018-53552
• Device Sequence Number: 13787439
• Product Code: MBI
• UDI-Device Identifier: 10886705001842
• UDI-Public: 10886705001842
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2015

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: 01/31/2018
• Device Catalogue Number: 212036
• Device Lot Number: 3662383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2015
• Initial Report FDA Received Date: 08/06/2018
• Patient Sequence Number: 1