MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/ 2 UB-BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202625
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the twinfix ultra screw tip broke off.After pushed the position with the corresponding awl, the implant is torn in the middle when screwing it into the bone.The piece fragments were completely removed from the patient without any problem.A s&n back-up device was available to complete the procedure.Neither significant surgical delay nor patient injuries have been stated.The patient bone quality was a very soft; the awl could have been inserted into the bone to the desired mark without a hammer.Nevertheless, for insertion site preparation, it was used the s&n matching awl with a hammer.
Additional Manufacturer Narrative
One (b)(4) 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: 1) alternate prep method, instruments or method used.2) incompatible or unexpected bone density/condition.3) incomplete anchor insertion.1) unexpected bone condition/density.2) use of excess torque.3) loss of or lack of axial alignment.Instructions for use are quite specific for this device.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/ 2 UB-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: 8310010
• Report Number: 1219602-2019-00150
• Device Sequence Number: 2322073
• Product Code: MBI
• UDI-Device Identifier: 03596010647535
• UDI-Public: 03596010647535
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 72202625
• Device Lot Number: 2017807
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR