MAUDE Adverse Event Report: ETHICON INC. COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	J841D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Suture needle broke: adult female patient: lumbar laminectomy & fusion - at closing needle broke during subcuticular-running closure - #1 vicryl figure-of-8.Sub c done w/2-0 vicryl - 30 quill) utilized c-arm to find the 2º piece - found piece immediately.There was no patient harm.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; route 22 west p.o. box 151; somerville NJ 08876
• MDR Report Key: 11444309
• Report Number: 11444309
• Device Sequence Number: 3618274
• Product Code: GAM
• UDI-Device Identifier: 10705031043244
• UDI-Public: (01)10705031043244
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/17/2021
• Report Date (Section F): 02/17/2021

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 Model Number: J841D
• Device Catalogue Number: J841D
• Device Lot Number: QLMAXK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 89
• Date Report Sent to FDA: 02/17/2021