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

Model 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
Product complaint # (b)(4).Date sent to the fda: 03/05/2020.Evaluation: an empty opened winding former and a dispensed needle-suture of product was received for analysis.During the visual inspection of the opened sample, the barbs were presented damaged and body fluids along strand were noted; however, the first loop was busted and consequently the second loop was missing.In addition, the other extreme of suture was damaged and cut appears to be by use of surgical instrument.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the condition of the sample, problem was likely to be caused by an improper handling of the sample.
Event or Problem Description
It was reported that a patient underwent an unknown surgery and the barbed suture was used.During surgery, it was found that the suture did not have a loop.There were no adverse patient consequences reported.Upon evaluation of the returned sample it was found that the loop was busted and consequently the second loop was missing.

• 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
• MDR Report Key: 9794679
• Report Number: 2210968-2020-01781
• Device Sequence Number: 11345597
• 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): 02/13/2020

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 Model Number: SXPP1B111
• Device Catalogue Number: SXPP1B111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1