MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX 3.5 TI ANC W/ ULTB SUTURE W/NEED; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203784
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two needles were released from the thread during the surgical procedure using the twin-fix titanium anchor.It is unknown if there were delays and how was the procedure completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 72203784 twinfix ti 3.5mm suture anchor reported on.Product was not returned for evaluation.Due to unavailability, visual evaluation was not possible.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) unexpected bone condition/density.2) alternate prep method, instruments or method used.3) use of excess torque.4) incomplete anchor insertion.5) loss of or lack of axial alignment.Instructions for use are specific for this device.Per ifu: ¿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.Complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: TWINFIX 3.5 TI ANC W/ ULTB SUTURE W/NEED
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10077622
• Report Number: 1219602-2020-00808
• Device Sequence Number: 3924070
• Product Code: MBI
• UDI-Device Identifier: 00885554029277
• UDI-Public: 885554029277
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K123425
• 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): 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2024
• Device Catalogue Number: 72203784
• Device Lot Number: 2027437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/20/2020
• 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; Required Intervention