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

Catalog Number Z880G

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please clarify the product code(s) of the device(s) used in this procedure.The sales rep called to report that the product code is 7880, not 7880e.He has it in his possession.The original product code reported was 7880e, for an ethicon e-pack.The lot number provided, kam487, corresponds to product code z880g.Was an ethicon e-pack used for this procedure? no.What were the product codes and lot numbers of the three needles that bent? same representative samples were examined for visual defects and none was found; these packets were opened and the needles were attached to the sutures.The swage area of the needle-sutures was examined for visual inspection attribute defects and no attachment defects or needle bending was noted.All needles presented good condition.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The needle kept bending while suturing.The procedure was completed using another like device.There was no patient consequence reported.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: PDS II (POLYDIOXANONE) SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5691207
• MDR Text Key: 46283894
• Report Number: 2210968-2016-09362
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: Z880G
• Device Lot Number: KAM487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2016
• 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