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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Visual observation revealed no anomalies with the inserter.The anchor was not sent back.The ethibond suture is frayed and cut as reported.This complaint can be confirmed.We cannot discern a root cause for this failure mode.Based on the complaint rate and customer impact, we believe this to be an anomaly.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 in time, no corrective action is required and no further action is warranted.A non-conformance search was performed for this product code 212036-lot #3919718, combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.
Event or Problem Description
It was reported by the customer that during a brow lift surgical procedure, it was observed that the suture broke on the tacit qa #2/0 eth v5+ hand drbt device.There was a five-minute delay in the surgical procedure as an identical spare device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 8277898
• Report Number: 1221934-2019-56121
• Device Sequence Number: 1691680
• Product Code: MBI
• UDI-Device Identifier: 10886705001842
• UDI-Public: 10886705001842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K961094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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: 07/31/2021
• Device Catalogue Number: 212036
• Device Lot Number: 3919718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1