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

Catalog Number 7209485

Device Problem Material Separation (1562)

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

Event Date 04/23/2020

Event Type  malfunction  

Event Description

It was reported that during a meniscus repair surgery, but before use; the two loop retrievers of the "set meniscus mender ii" were already disassembled between head and shaft when the package was opened.Although it is unknown if backup device was available, there is no confirmation that reasonably suggests the procedure cancellation, a change in the surgical technique, nor the use of a competitor device occurred.However, the surgery was not delayed and no patient injuries or other complications were reported.

Manufacturer Narrative

H10 h6: one 7209485 disposable meniscus mender ii set used in treatment, was returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.The allegation was observed.Policy is to return product as found.The snare loop wires were broken at the head to shaft weld.To avoid components from shifting within the package, individual component storage cradles are intentionally snug.The heads of the braided loop components snap into their packaging cavities.Use of the distal end (head) to remove snare loops from the tray may result in weakening, bending or complete fracture between at the head and shaft connection.Proper method of retrieval is to push and pop the head of the component from the back of the cradle.Complaint history review indicated similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.The condition was confirmed during further investigation by engineering.

Manufacturer Narrative

One 7209485 disposable meniscus mender ii set used in treatment, was returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.The allegation was observed.Policy is to return product as found.The snare loop wires were broken at the head to shaft weld.To avoid components from shifting within the package, individual component storage cradles are intentionally snug.The heads of the braided loop components snap into their packaging cavities.Use of the distal end (head) to remove snare loops from the tray may result in weakening, bending or complete fracture between at the head and shaft connection.Proper method of retrieval is to push and pop the head of the component from the back of the cradle.Complaint history review indicated similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.The condition was confirmed during further investigation by engineering.This resulted with initiation of a corrective action and potential process change.The product family is under review via corrective action.Engineering evaluation confirmed the product met specifications at the time of distribution.

Manufacturer Narrative

The reported disposable meniscus mender ii kit, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.However, a trend of this nature has been observed with this product in the field, prompting a root cause investigation.As a process improvement, smith and nephew worked with our supplier, to implement a process change to improve the suture capture loop¿s device strength.In addition the laser welding process was adjusted and a revalidation was conducted.The process change was implemented into production.These changes were conducted in parallel to the root cause investigation.Once the root cause investigation is finalized, a subsequent process change may or may not be required to meet the new design requirements.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 10067967
• MDR Text Key: 191377089
• Report Number: 1219602-2020-00793
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 3596010468482
• 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,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209485
• Device Lot Number: 2037273
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2020
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1