MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 3-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8558H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Edema (1820); Erythema (1840); Inflammation (1932); Not Applicable (3189); Swelling/ Edema (4577)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 clarify 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.The patient demographic info: weight, bmi at the time of index procedure.Please clarify a date of index surgical procedure? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was the suture initially placed (interrupted or continuous)? how the suture was initially tied? was there any precipitating stress factor for the suture slippage and breakage? other relevant patient comorbidities/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient current status? what suture product was used to resuture?.
Event or Problem Description
It was reported that the patient underwent a right hand tendon rupture repair surgery on unknown date in 2020 and the suture was used for tendon anastomosis.Seven days after the surgery, the edge of the incision appeared with erythema and post-op inflammation.The incision was opened immediately and edema of subcutaneous tissue was found along with slippage of suture and partial broken suture.The suture was removed and the tendon was anastomosed again with a new suture.One week later, the incision healed.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 12/04/2020.H6 component code: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Additional information was requested, and the following was obtained: please clarify a date of index surgical procedure?--it was performed on (b)(6) 2020.What is the patient current status? it was reported that the patient's incision healed a week after removal of the suture and replacement of suture.The following information was requested, but unavailable: "the patient demographic info: weight, bmi at the time of index procedure.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was the suture initially placed (interrupted or continuous? how the suture was initially tied? was there any precipitating stress factor for the suture slippage and breakage? other relevant patient comorbidities/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to these events? what suture product was used to re-suture? this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.

• Brand Name: PRLNE BLU 36IN 3-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10651790
• Report Number: 2210968-2020-07782
• Device Sequence Number: 2963101
• Product Code: GAW
• UDI-Device Identifier: 10705031017092
• UDI-Public: 10705031017092
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 8558H
• Device Catalogue Number: 8558H
• Device Lot Number: PBH065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR