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	02/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The expiration date is not currently available.
Event or Problem Description
It is used in tacit 2.0mm mitek anchor surgery and the expected result was not obtained, dr.(b)(6) performed correct technique, bone piercing, release of the sutures of the inserter handle and when checking the anchor grip, it is frees from the cortical bone.Retry the insertion of the anchor without obtaining the expected result.So he decided to place input from another provider which is fixed immediately.The event leaves as a consequence only an input that we can not charge since it could not be used on the patient.Patient resolves his problem with an anchor from another provider so there are no delays in the surgical procedure.
Event or Problem Description
Event: it is used in tacit 2.0mm mitek anchor surgery and the expected result was not obtained, dr.Performed correct technique, bone piercing, release of the sutures of the inserter handle and when checking the anchor grip, it is frees from the cortical bone.Retry the insertion of the anchor without obtaining the expected result.So he decided to place input from another provider which is fixed immediately.The event leaves as a consequence only an input that we can not charge since it could not be used on the patient.Patient resolves his problem with an anchor from another provider so there are no delays in the surgical procedure.
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) incomplete.The expiration date is not currently available.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.There were no anomalies with the inserter that would have contributed to the reported failure.The ends of the returned sutures were a little frayed, indicating a probability that the user might have applied an excessive tension damaging the suture, and pulling out the anchor.The complaint can be confirmed.A dhr 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 evidence of manufacturing anomalies on the paperwork reviewed.A review into the mitek complaints system revealed no other complaint of any kind for this lot of devices.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).

• 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: 7349327
• Report Number: 1221934-2018-50316
• Device Sequence Number: 1094004
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2018

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: 09/30/2022
• Device Catalogue Number: 212036
• Device Lot Number: L529168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 04/09/2018; 06/05/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 05/07/2018; 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 72