MAUDE Adverse Event Report: ETHICON MONOCRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y417

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2014

Event Type  malfunction  

Event Description

While closing, the physician noted the tip of the needle broke off.Manufacturer response for needle break, (brand not provided) (per site reporter).
=
gave physician a heavier needle for these types of cases and no further breaks.

• Brand Name: MONOCRYL
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON; rt. 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 4205810
• MDR Text Key: 16856551
• Report Number: 4205810
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2014

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 Catalogue Number: Y417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2014
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 50 YR