MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON POLYSORB 1 30 VIOLET HGS-21; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	CL932
Medical Device Problem Codes	Break (1069); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, during an emergency c-section procedure and while closing the first layer of uterus the surgeon, experienced that the needle was easy to pass through tissue and then after couple of throws there was a bit of resistance in passing needle through tissue.The top of the needle tip broke from its body and it couldn't be retrieve during the procedure.Surgical time was extended 30 minutes as an intraoperative x ray was taken of the patient to find the needle tip but was unsuccessful.The patient had a normal length and of stay at the hospital as required due to the nature of surgery.The patient has since been discharged from the hospital.The surgeon believes that the tip will, as a foreign body, will be encapsulated by tissue.
Additional Manufacturer Narrative
(b)(4).Product returned, evaluation pending.
Additional Manufacturer Narrative
(b)(4).Post market vigilance (pmv) led an evaluation of one suture opened by the account and four sealed sutures.A tactile and microscopic inspection of the sealed sutures was performed with no abnormalities.The visual inspection of the opened sample noted one suture segment and one needle; the needle was received with the needle tip broken.Upon microscopic inspection of the needle, instrument marks were observed at the break site.The foils were inspected with light assisted microscopy with no abnormalities.Additionally, bend moment and penetration force testing was performed on the sealed samples and the result exceeded specifications for this product.The observed instrumentation damage suggests that the needles were grasped improperly at the needle tip during application.Firmly grasping the needle at the tip weakens the needle causing it to bend and/or break.The recommended grasping area of the needle is at the needle body, where the wire is of a full diameter.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: POLYSORB 1 30 VIOLET HGS-21
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5603456
• Report Number: 1219930-2016-00363
• Device Sequence Number: 13694492
• Product Code: GAM
• UDI-Device Identifier: 20884521043494
• UDI-Public: (01)20884521043494(17)201031(10)A5K1133WX
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: CL932
• Device Catalogue Number: CL932
• Device Lot Number: A5K1133WX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/25/2016
• Supplement Report FDA Received Date: 06/02/2016; 11/20/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other