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

Model Number 7209485

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2020

Event Type  malfunction  

Event Description

It was reported that when the doctor opened the meniscal repair system, both of the suture passers were broken at the base in the package.The package was not damaged.The item never touched the patient nor did it make it to the back table.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: 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.A snare loop wire was 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 did not indicate a condition, product or procedure failure that supported the allegation although the condition was confirmed during further investigation by engineering.The product family is under review via corrective action.Engineering evaluation confirmed the product met specifications at the time of 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: 10136259
• MDR Text Key: 194615779
• Report Number: 1219602-2020-00869
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2024
• Device Model Number: 7209485
• Device Catalogue Number: 7209485
• Device Lot Number: 2034277
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1