MAUDE Adverse Event Report: ETHICON, INC. ETHICON MONOCRYL REVERSE CUTTING SUTURE NEEDLE; SUTURE, ABSORBABLE, SYNTHETIC, NEEDLE

Model Number 4-0

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

Just after the closing surgical count, surgeon informed staff that the tip of a 4-0 monocryl needle broke off just as the suture had passed through the skin.X-ray done to assure needle tip not in surgical field or patient.Procedure completed, no patient harm.

• Brand Name: ETHICON MONOCRYL REVERSE CUTTING SUTURE NEEDLE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, NEEDLE
• Manufacturer (Section D): ETHICON, INC.; route 22 west p. o. box 151; somerville NJ 08876
• MDR Report Key: 4683283
• MDR Text Key: 5689316
• Report Number: 4683283
• Device Sequence Number: 1
• Product Code: GAN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/10/2015

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
• Device Operator: Physician
• Device Model Number: 4-0
• Device Catalogue Number: Y426H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2015
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 86