MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.The actual device product code and batch number associated with this event is not known.The following possible product codes and batch numbers: possible product codes: sxpp1a445 and sxpp1a400.Possible batch numbers: pmu080 and ppmbqt.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent a prostatectomy on (b)(6) 2020 and the barbed suture was used.During surgery, the tab broke off in this case.Surgery was not delayed due to the reported event.There were no patient consequences reported.

Manufacturer Narrative

Date sent to the fda: 01/27/2021.H6 component code: g07002 ¿ conforming device.Additional information: d4, h4 ¿ the actual device product code and batch number associated with this event is not known.The following possible product codes and batch numbers are: product code sxpp1a400 lot ppmbqt exp.Date 11/30/2021; mfr.Date 12/04/2019; product code sxpp1a445 lot pmu080 exp.Date 10/31/2021; mfr.Date 11/21/2019.In addition, a manufacturing record evaluation was performed for the possible finished device lot numbers ppmbqt (product code sxpp1a400) and pmu080 (product code sxpp1a445), and no non-conformances related to the reported complaint condition were identified.Additional information: d9, h6.Additional h-3 summary: it was received for analysis an unopened sample of product code sxpp1a400, lot ppmbqt.During the visual inspection of the unopened sample, no defects were found on the package.The sample was opened, and the swage and attachment area of the needle was noted to be as expected.The suture was examined, the barbs were present along of the strand and the tabs were as expected.It was received for analysis an unopened sample of product code sxpp1a445, lot pmu080.During the visual inspection of the unopened sample, no defects were found on the package.The sample was opened, and the swage and attachment area of the needle was noted to be as expected.The suture was examined, the barbs were present along of the strand and the tabs were as expected.Additional event information obtained: there is only one stratafix symmetric tab breakage occurred and lot number is unknown.Lots pmu080 and ppmbqt are possible, pulled from the shelf and maybe used during surgery.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: STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11090941
• MDR Text Key: 224395714
• Report Number: 2210968-2020-10377
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• PMA/PMN Number: K113004
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 12/29/2020
• Patient Sequence Number: 1