MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MNITAC,2.0 TI W/NDL,2#2-0 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number	72202019
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 72202019 2.0 titanium minitac with needles and ultrabraid device reported on.The complaint stated: ¿the sutures were being used to tie over the tendons, the anchor came out completely from the operation site.¿ primary causes for anchor pull out are incomplete anchor insertion, inadequate bone condition; density or oversized tunnel.Per instructions for use: ¿bone quality must be adequate to allow proper placement of suture anchor.¿ the ultrabraid sutures are absent from the return.The four stainless steel needles are absent.Only the handle/shaft assembly and the titanium anchor were returned.The handle rotates 90 degrees as expected.The anchor is whole but does have dings and gouges present.Instructions for use states: ¿do not use sharp instruments to manage or control the suture.Hard bone conditions require preparing the insertion site to reduce the potential of torsional overload.Predrilling with the appropriate drill is the preferred method of insertion site preparation.Predrilling extracts the core diameter of the anchor for the insertion device tip.If the quality of the bone cannot be determined, smith and nephew recommends the predrilling option prior to implanting any soft tissue anchor.Ensure the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair.Only use the appropriate drill bits and drill guides intended for use with the mini tac suture anchor or the implant may not be properly aligned.¿ requests for further information were unsuccessful.It is unknown what drill bits/guides were used for prep.No root cause related to the manufacture of this device was confirmed.(b)(6).
Event or Problem Description
It was reported that during a wrist scope kiv tfcc repair, when the sutures were being used to tie over the tendons, the anchor came out completely from the operation site.Sutures were removed from the patient and another anchor was inserted.No significant delay or patient injuries were reported.The back up device was used in a different hole.

• Brand Name: MNITAC,2.0 TI W/NDL,2#2-0 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8704547
• Report Number: 1219602-2019-00708
• Device Sequence Number: 1876413
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: 03596010619013
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K000797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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: 06/25/2020
• Device Catalogue Number: 72202019
• Device Lot Number: 50555110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1