MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TFCC MENDER DISPOSABLE SUTURE SYSTEM; PASSER

Model Number 7210752

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during a knee surgery, a screw broke while being tapped.It is unknown whether all fragments were retrieved from the patient.A back-up screw went in and held.It is unknown how long surgery was delayed.The patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.On (b)(6) 2020, smith & nephew received a complaint against two tfcc mender disposable suture system devices (part number: 7210752; lot numbers: 50646756 (x1) & 50727527 (x1)).It was reported that, during a knee surgery, two screws broke while being tapped.It is unknown whether all fragments were retrieved from the patient.A back up screw went in and held.It is unknown how long surgery was delayed.The patient was not harmed.Consequently, on (b)(6) , smith & nephew filed two reports for this incident: 1219602-2020-00448 & 1219602-2020-00449 (one for each device).The reporting decision was then made based on two criteria: (1) an intraoperative breakage; and (2) the lack of a back-up device.Nonetheless, on (b)(6) 2020, the reporting source indicated that the initial information was erroneous and proceeded to amend as follows: it was reported that, during a knee surgery, two tfcc mender suture systems broke as they came out of the packaging.A back-up device was used to complete the procedure.The surgery was delayed, but is unknown for how long.The patient was not harmed.Therefore, the re-assessment of this case determined that, since the previously enlisted criteria 1-2 are no longer met, the issue does not meet either the threshold for reporting and is now a non-reportable event.These reports were submitted based upon information that smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: TFCC MENDER DISPOSABLE SUTURE SYSTEM
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9772685
• MDR Text Key: 182169448
• Report Number: 1219602-2020-00448
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010563279
• UDI-Public: 03596010563279
• Combination Product (y/n): N
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: 7210752
• Device Catalogue Number: ED7210752
• Device Lot Number: 50646756
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1