MAUDE Adverse Event Report: ETHICON INC. ETHI-PACK STEEL SIL 12X18IN 7 NON NDL; SUTURE, NONABSORBABLE, STEEL

Model Number	DS18
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: could you please clarify if the patient suffered from any signs or consequences due to the issue? product was not used on a patient.Could you please clarify if the issue was received product that is not within the same product family? product is ethi-pack ds18 7 (9.0 metric) 18¿.What is the lot number? lot jbf2111060.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: g07002 ¿ device not returned.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2022 and suture was used.The customer reported that the suture is not actually 18 gauge, it is thinner.The surgeon noticed a difference and it is thinner than a spool of 18 gauge wire they had previously.The product was not used on the patient.There were no adverse consequences reported.Additional information was requested.

• Brand Name: ETHI-PACK STEEL SIL 12X18IN 7 NON NDL
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16158469
• Report Number: 2210968-2023-00324
• Device Sequence Number: 20584379
• Product Code: GAQ
• UDI-Device Identifier: 10705031036703
• UDI-Public: 10705031036703
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K931271
• 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

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 Model Number: DS18
• Device Catalogue Number: DS18
• Device Lot Number: JBF2111060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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