MAUDE Adverse Event Report: ETHICON INC. PDS+ U 45 CM M1.5 PS-4 MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number PDP509G

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: any alleged deficiency/non-conformance with the device noted that caused or contributed to the patient events? no further information is available.Will there be any future intervention or attempts to retrieve the broken needle? no further information is available.What is current condition of the patient? the patient has been discharged.The procedure was breast conservation surgery.Lot number? the lot number is unknown.Device return status / follow up? when we send the sample to you, we will let you know its return date and tracking number.No further information will be provided.

Event Description

It was reported that the patient underwent a breast conservation surgery on (b)(6) 2019 and suture was used.The surgeon felt that the needle became dull while he was doing interrupted suturing by instrument tying.When he checked the needle tip, it was found that the needle tip had been broken.The broken needle tip could not be found on the surgical field nor the instrument table.It could not be found on x-ray images, neither.So, the surgery was completed without finding the broken needle tip.There were no adverse consequences to the patient.The patient has been discharged.Additional information has been requested.

• Brand Name: PDS+ U 45 CM M1.5 PS-4 MP
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9261150
• MDR Text Key: 177355157
• Report Number: 2210968-2019-89178
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031207240
• UDI-Public: 10705031207240
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PDP509G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1