MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET MENISCUS MENDER II DISPOSABLE; PASSER

Model Number 7209485

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 arthroscopy, 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, but the surgery was delayed more than 30 min.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

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.On february 6th 2020, smith & nephew received a complaint against two set meniscus mender ii disposable devices (part number: 7209485; lot number: 2031439).It was reported that, during a knee arthroscopy, 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, but the surgery was delayed more than 30 min.The patient was not harmed.Consequently, on march 1st, smith & nephew filed two reports for this incident: 1219602-2020-00446 & 1219602-2020-00447 (one for each device).The reporting decision was then made based on three criteria: (1) an intraoperative breakage; and (2) the lack of a back-up device that (3) led to a surgical delay greater than 30 min.Nonetheless, on march 26th 2020, the reporting source indicated that the initial information was erroneous and proceeded to amend as follows: it was reported that, during a knee arthroscopy, the needle of two meniscus mender ii came off the stem when taken out of the box: packaging was too tight and needles were too delicate.The surgery was completed with a back-up device; although surgery was delayed, it is unknown for how long.The patient was not harmed.Therefore, the re-assessment of this case determined that, since the previously enlisted criteria 1-3 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: SET MENISCUS MENDER II DISPOSABLE
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9772682
• MDR Text Key: 181964743
• Report Number: 1219602-2020-00447
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 03596010468482
• 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 Model Number: 7209485
• Device Catalogue Number: 7209485
• Device Lot Number: 2031439
• 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