MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/3UB-WHT BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202600
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a rotator cuff repair surgery, the twinfix ultra anchor broke above the eyelet while being inserted.The fragments were removed from the patient, but it is unknown how.A s&n back-up device was available to complete the procedure, but it is unknown whether it was necessary to drill another bone hole to use it.Neither significant surgical delay nor patient injuries were disclosed.
Additional Manufacturer Narrative
One 72202600 twinfix ultra pk 5.5mm suture anchor reported on.Product was not returned for evaluation.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 4) alternate prep method, instruments or method used.5) incompatible or unexpected bone density/condition.6) incomplete anchor insertion.4) unexpected bone condition/density.5) use of excess torque.6) loss of or lack of axial alignment.Instructions for use are quite specific for this device.Per instructions for use : ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.If more torque is required to insert the anchor, stop and ensure that the drill bit size and depth are correct.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Final product met specifications upon release to distribution.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/3UB-WHT BL &BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8372426
• Report Number: 1219602-2019-00246
• Device Sequence Number: 16675908
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: 03596010647481
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093228
• 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
• Report Date (Section B): 03/26/2019

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 Catalogue Number: 72202600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1