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

Model Number 7209485

Device Problem Break (1069)

Patient Problems Chills (2191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during surgery, the needle of the meniscus mender broken when inserting it into the knee.It is unknown whether there was a back up available or delay in the case.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during knee arthroscopy surgery, the needle of the meniscus mender broken when inserting it into the knee.The piece was removed from the patient and a backup device was available to complete the procedure with no significant delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a isolated issue.A review of the instructions for use found: read these instructions completely prior to use.Associated instruments for the meniscus mender ii kit are sold separately and are provided non-sterile.These instruments must be properly cleaned and sterilized prior to use.Prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.Use of this kit is recommended only for those tears that appear in the outer one-third of the meniscus.Use in other regions of the meniscus, though not harmful, will not render the same results.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Health effect - clinical code corrected.

• Brand Name: SET MENISCUS MENDER II DISPOSABLE
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11115048
• MDR Text Key: 225051390
• Report Number: 1219602-2021-00022
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 7209485
• Device Catalogue Number: 7209485
• Device Lot Number: 2057162
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/07/2021; 02/04/2021
• Supplement Dates FDA Received: 01/18/2021; 02/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other