MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN D/A CTX; CLASS I DEVICE - EXEMPT

Model Number RS22

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot number (b)(4), and no non-conformances were identified.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.Investigation summary: it was reported breakage suture.One picture was received for analysis.Upon visual inspection of the picture, one open overwrap, one open foil and one needle-suture pieces could be observed; however, the needle-suture not belong to product code (b)(4).The needle required for product code (b)(4) is taper point needle, half circle of curve, sales type ctx and the needle showed in the picture is a straight needle.Therefore, no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

Event Description

It was reported that the patient underwent cervical cerclage on 6/2/2020 and suture was used.The suture broke when sewing during the procedure.Changed to another device to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.

Manufacturer Narrative

Date sent to the fda: 07/23/2020.Additional h-3 summary: it was reported breakage suture.One empty open overwrap, one open foil and one needle-suture piece of product were received for analysis.During the visual inspection of the needle/suture piece, the swage and attachment area were noted to be as expected.However, marks on the body needle were observed and the shape of needle was distorted due to use.The suture was examined, and the end was cut appears to be by the use of a surgical instrument could be observed.Due to the condition of the sample the functional test can¿t be performed.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: MERS TAPE WHT 12INX3/16IN D/A CTX
• Type of Device: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10155103
• MDR Text Key: 195253721
• Report Number: 2210968-2020-04573
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: RS22
• Device Catalogue Number: RS22
• Device Lot Number: PCH144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1