MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 30CMX5MM S/A MO-4; CLASS I DEVICE - EXEMPT

Catalog Number RS23

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent gynecological procedure on (b)(6) 2019 and suture was used.During the cervical cerclage, the needle broke in half passing through the cervix.Both pieces were retrieved without further incident.The procedure was completed with another device of the same product code.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent to the fda: 05/31/2019.Device evaluation summary: the actual device was received for evaluation.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.The fracture surfaces were microscopically examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage and macroscopic plastic deformation observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The needle breakage was confirmed.The manufacturing records couldn't be reviewed as the batch number is unknown.

• Brand Name: MERS TAPE WHT 30CMX5MM S/A MO-4
• Type of Device: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8591861
• MDR Text Key: 144835602
• Report Number: 2210968-2019-81183
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049826
• UDI-Public: 10705031049826
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RS23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Date Manufacturer Received: 05/27/2019
• Patient Sequence Number: 1