MAUDE Adverse Event Report: ETHICON INC. PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE; SUTURE, SURGICAL, ABSORBABLE

Catalog Number PDP316H

Device Problem Needle, separation (1415)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2014

Event Type  malfunction  

Manufacturer Narrative

Conclusion: one needle/suture in two pieces was returned for evaluation.Upon visual evaluation, there was a suture piece attached in the needle.It was observed that the suture was damaged and the end was cut.No attachment defects were found.There were several marks on the needle piece by use of the needle holder.The sample condition suggests an improper handling of the needle/suture.

Event Description

It was reported that the patient underwent total laparoscopic cystectomy on (b)(6) 2014 and suture was used.The needle broke at the swage when the doctor was making continuous sutures through the myometrium and the doctor opines that the breakage felt like the suture pulled off the swage of the needle.The needle piece was retrieved and the procedure was completed successfully.There was no adverse patient consequence.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4021149
• MDR Text Key: 12175151
• Report Number: 2210968-2014-11786
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PDP316H
• Device Lot Number: HA6927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1