MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 0 S/A CT LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	D6361
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in medwatch reports 2210968-2021-09240, 2210968-2021-09241.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.Additional information was requested and the following information was obtained: what is the lot number of the 3 broken sutures? lot number of the 3 packages is pmm493.When were the sutures broke (in the package, during removal from package, during handling or during use on the patient)? please specify - and it was broke when we were trying to suture the patient during an anterior back surgery.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a spinal procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/15/2021.H6 component code: g07002 no device return.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: PDSII VIO 60IN 0 S/A CT LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12582995
• Report Number: 2210968-2021-09242
• Device Sequence Number: 3787663
• Product Code: NEW
• UDI-Device Identifier: 10705031026292
• UDI-Public: 10705031026292
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: D6361
• Device Catalogue Number: D6361
• Device Lot Number: PMM493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown