MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 6IN 4-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B427

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/28/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a ralp:robot assisted laparoscopic prostatectomy on (b)(6) 2022 and a barbed suture was used for vesicourethral anastomosis.During the procedure, the suture was broken and cut from the needle during continuous suturing.As a result of searching the body cavity for about 1 hour, only the needle was found, but the suture seemed to have gone somewhere.The operation time was extended more than 30 minutes.Additional information was requested.

Manufacturer Narrative

(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.(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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what instruments were used in this procedure to handle the suture? did the needle pull off the stratafix suture during the procedure? did the stratafix suture break during the procedure? if so, where was the break noted (termination, middle, end)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe any medical/surgical intervention required for this suture event including results.Was the entire needle located and removed from the patient during the initial procedure? was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome) due to the prolonged surgery? was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome) due to the suture piece that is missing in the patient¿s body? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: no further information is available.The diagnosis and indication for the index surgical procedure? no further information is available.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? ralp:robot assisted laparoscopic prostatectomy.On what tissue was the suture used? no further information is available.What was the tissue condition (normal, thin, calcified, fragile, diseased)? no further information is available.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? no further information is available.Was at least one reverse stitch performed prior to closure? no further information is available.What instruments were used in this procedure to handle the suture? no further information is available.Did the needle pull off the stratafix suture during the procedure? no further information is available.Did the stratafix suture break during the procedure? if so, where was the break noted (termination, middle, end)? no further information is available.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no further information is available.Please describe any medical/surgical intervention required for this suture event including results: no further information is available.Was the entire needle located and removed from the patient during the initial procedure? yes.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.No further information is available.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome) due to the prolonged surgery? no further information is available.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome) due to the suture piece that is missing in the patient¿s body? no further information is available.What is the physician¿s opinion as to the etiology of or contributing factors to this event? no further information is available.What is the patient's current status? no further information is available.Lot number? no further information is available.

Manufacturer Narrative

(b)(4) date sent to the fda: 12/21/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional h3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that it was received one empty labeled winding former and a needle that pertain to product code sxpp1b427.In order to evaluate the conditions of the detached needle, the swage area and hole were noted with marks by a surgical instrument.In the hole was observed a suture piece.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Device history lot: the manufacturing records couldn't be reviewed as the batch/lot number is unknown.

• Brand Name: SFX SPI PDS+ UNI VIO 6IN 4-0 S/A RB-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15804121
• MDR Text Key: 303708423
• Report Number: 2210968-2022-09484
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236196
• UDI-Public: 10705031236196
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1B427
• Device Catalogue Number: SXPP1B427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/17/2022; 12/13/2022
• Supplement Dates FDA Received: 11/29/2022; 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention