MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	7210708
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when surgeon inserted the anchor into the bone, deployed the needles.Only 3 of the 4 suture had needles on.The fourth needle broke off from the suture during deployment.Surgeon used a curved mayo needle from the pharmacy in order to complete his suturing.No patient injury was reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.
Additional Manufacturer Narrative
The return consisted of one single needle head.There is no portion of suture included.There are instrument bite marks present.There are three needles; the associated sutures, the titanium anchor and the device absent, therefore, no simulation test could be performed.Hard bone conditions require preparation by predrilling the insertion site to reduce the potential of torsional overload.Predrilling extracts the core diameter of the suture anchor and creates a countersink broach for insertion of the device tip.Predrilling with the appropriate drill bit is the preferred method of site preparation.Excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.If more torque is required to insert the anchor, stop and ensure that the drill bit size and depth are correct.Root cause cannot be confidently assessed without more than one needle returned.

• Brand Name: TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7406267
• Report Number: 1219602-2018-00422
• Device Sequence Number: 19226261
• Product Code: MBI
• UDI-Device Identifier: 03596010532206
• UDI-Public: (01)03596010532206(17)221027(10)50693525
• Combination Product (Y/N): N
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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: 10/27/2022
• Device Model Number: 7210708
• Device Catalogue Number: 7210708
• Device Lot Number: 50693525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/09/2018; 06/22/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/14/2018; 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1