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

Catalog Number	212236
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/10/2019
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.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during the lift up surgery, it was observed that the tacit quick anchor was implanted into the patient's body.After the suture was attached with the anchor, and while closing, it was reported that the surgeon recognized that all threads were broken.The surgeon removed the anchor and implanted an alternative anchor into the same position to complete the surgery.There was approximately a fifteen minute surgical delay and no harm to the patient was reported.It was brand new and the first use when the issue occurred.No further information was provided by the hospital.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: upon receipt, the complaint device was returned and found to be incomplete.The anchor was returned without the suture.Therefore, the reported failure of suture damaged cannot be verified as the suture was not available for a physical evaluation.Hence, this complaint cannot be confirmed.Moreover, we cannot determine a definitive root cause for the reported failure as no evaluation can be performed.However, the anchor was received and a visual inspection of the device was performed to detect any gross visual defects that may contribute to the complaint condition.Visual observation reveals that the threads on the anchor are slightly worn which is consistent with the information provided which states that the anchor was implanted and then removed from the patient.Furthermore, a non-conformance search was performed and no non-conformances were identified for this part (212236) with the lot number (3l18775) combination.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.Udi: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TACIT QA #2/0ETH 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: 8655594
• Report Number: 1221934-2019-57256
• Device Sequence Number: 1832260
• Product Code: MBI
• UDI-Device Identifier: 10886705002023
• UDI-Public: 10886705002023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 05/10/2019

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: 01/31/2024
• Device Catalogue Number: 212236
• Device Lot Number: 3L18775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/30/2019; 08/08/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/03/2019; 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1