MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 18IN 3-0 SA SH; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A410
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/27/2024.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information was requested, the following was obtained: what is the lot number? unk.Are there photos available? no.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) (b)(6).The following information was received: finally, the surgery was completed without problems using sxpp1a410 as originally planned.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 or Problem Description
It was reported that the patient underwent a spinal surgery on an unknown date and barbed suture was used.During a spine surgery, the doctor asked for two packs of symmetric sutures, and the nurse gave him two packs of spiral sutures.The doctor then instructed her to put out symmetric again, and the nurse put out two packages of symmetric sutures.However, one of packages was spiral suture.He again pointed out to the nurse that it was wrong, but the nurse showed him the outer package and he was able to confirm that it was the symmetric package.The nurse said that the symmetric package was opened and contained spiral.But the doctor did not see it being put out, so the doctor thought that it must have been the nurse's mistake.It was not a control release needle.There were no adverse consequences to the patient.Additional information was requested.

• Brand Name: SFXSYM PDS+ UNI VIO 18IN 3-0 SA SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20076950
• Report Number: 2210968-2024-08995
• Device Sequence Number: 17776377
• Product Code: NEW
• UDI-Device Identifier: 10705031219311
• UDI-Public: 10705031219311
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: SXPP1A410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown