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

Catalog Number	PDP509G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9261150
• Report Number: 2210968-2019-89178
• Device Sequence Number: 19773817
• Product Code: NEW
• UDI-Device Identifier: 10705031207240
• UDI-Public: 10705031207240
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: PDP509G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/31/2019
• Patient Sequence Number: 1