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

Model Number	7210752
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9772685
• Report Number: 1219602-2020-00448
• Device Sequence Number: 11309087
• Product Code: HWQ
• UDI-Device Identifier: 03596010563279
• UDI-Public: 03596010563279
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K885311
• 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): 03/31/2020

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 Expiration Date: 02/13/2022
• Device Model Number: 7210752
• Device Catalogue Number: ED7210752
• Device Lot Number: 50646756
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/01/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1