MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI 6IN 4-0 SA PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: it was received for analysis an empty opened foil, an empty labeled winding former and a dispensed needle-suture of product code sxpp1b111, lot mph889.During the visual inspection of the opened sample, the swage and attachment area were noted to be as expected and marks on the body needle were noted.The suture was examined the barbs were present along of strand; however, the first loop was busted and consequently the second loop was missing.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the condition of the sample, suggest an improper handling of the sample.A manufacturing record evaluation was performed for the finished device mph889, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.The loop of the suture came off during use.There were no adverse consequences to the patient.Upon evaluation of device returned, the first loop was busted.

• Brand Name: SFX SPI PDS+ UNI 6IN 4-0 SA PS-2 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8941779
• Report Number: 2210968-2019-86399
• Device Sequence Number: 2041896
• Product Code: NEW
• UDI-Device Identifier: 10705031236288
• UDI-Public: 10705031236288
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150670
• 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): 08/05/2019

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 Expiration Date: 11/30/2020
• Device Catalogue Number: SXPP1B111
• Device Lot Number: MPH889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/28/2019
• Patient Sequence Number: 1