MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 18IN 4-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B118
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 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 confirm the procedure was tka on (b)(6) 2019? the patient demographic info: gender at the time of index procedure? what tissue layer was each suture type used on? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? what date did the patient present with dehiscence (# post op days)? how was the dehiscence managed? what was the appearance of the stratafix spiral mon suture during the second procedure? did the tissue pull away from the stratafix spiral intact suture? was the stratafix spiral suture intact or broken? if broken, where (proximal, distal, end, middle)? can you identify the lot number reported in this event? are there pictures available that could be forwarded for review? are there sterile samples from the reported finished goods lot available for testing? were cultures performed? if so what were the culture results? did the patient have any pre-existing health issues that could contribute to healing issues which could have contributed to the event? (for example, medications, past reactions or allergies, weight, age, diabetes, obesity, etc)? did the patient fall or injury themselves in a way that may have affected the surgical area? was the patient compliant with post-op instructions? were antibiotics prescribed? also the doctor¿s experience and product placement technique? what is the patient¿s current health status and condition?.
Event or Problem Description
It was reported that the patient underwent a total knee arthroscopy on (b)(6) 2019 and barbed suture was used in the incision.The wound was irrigated prior to closure.Approximately 5-7 weeks post op, the patient presented with suture breakdown and infection, and superficial dehiscence.A second procedure was performed on an unknown date.The appearance of the suture during the second procedure was not provided.Additional information has been requested.

• Brand Name: SFX SPI MCRYL+ UNI 18IN 4-0 SA PS-2 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9628619
• Report Number: 2210968-2020-00686
• Device Sequence Number: 2913864
• Product Code: GAM
• UDI-Device Identifier: 10705031236707
• UDI-Public: 10705031236707
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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 Model Number: SXMP1B118
• Device Catalogue Number: SXMP1B118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR