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 Codes	Cyst(s) (1800); Pain (1994)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a rotator cuff surgery was performed in "2103." mri was performed on the shoulder because pain was reported, there was cysts around one and possibly two of the anchors.S.A.D was performed but the product was not removed from the patient.Device will not be returned.
Additional Manufacturer Narrative
Ocurrence date was 2013 instead of 2103.
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: 10) alternate prep method, instruments or method used.11) incompatible or unexpected bone density/condition.12) incomplete anchor insertion.10) unexpected bone condition/density.11) use of excess torque.12) 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.There is no objective evidence to suggest a direct link between the surgical site infection (ssi) and products used during the procedure.Final product met specifications upon release to distribution.
Event or Problem Description
It was reported that a rotator cuff surgery was performed in 2013.Mri was performed on the shoulder because pain was reported, there was cysts around one and possibly two of the anchors.S.A.D was performed but the product was not removed from the patient.Device will not be returned.

• 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: 8449672
• Report Number: 1219602-2019-00348
• Device Sequence Number: 2988934
• Product Code: MBI
• UDI-Device Identifier: 03596010647535
• UDI-Public: 03596010647535
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 72202625
• Device Lot Number: 50462058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 05/15/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 03/27/2019; 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other