MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL MONOCRYL+; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B110
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Swelling (2091); Not Applicable (3189)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 03/20/2018.(b)(4).Additional information was requested and the following was obtained: what tissue was the stratafix spiral suture used on? subcuticular what was the condition of the tissue where suture was used (normal, diseased, weakened)? patient had a higher bmi, surgeon noted after surgery the knee was swelled considerably.Was the stratafix spiral placed while the knee was in flexion? yes.Was there any patient predisposing event (cough, fall, etc) prior to wound opening? unknown.What is the surgeon opinion as to relationship of the stratafix suture and the patient dehiscence? patient had a higher bmi and significant swelling after surgery which may have contributed.What was the appearance of the stratafix spiral when the wound opened? unknown was a second procedure performed to close the wound? dermabond advanced was applied.Was the suture found broken, can you identify where (termination, middle, end)? unknown.Was the suture intact and pulled through the tissue? unknown.Can you identify the lot number of the sxmp1b110 stratafix spiral suture? no.What is the current condition of the patient? surgeon reported patient is doing fine.
Event or Problem Description
It was reported that a patient underwent total knee procedure on (b)(6) 2018 and barbed suture was used on subcuticular tissue.The morning of (b)(6) 2018 the patient experienced wound reopening from the proximal end to approximately the middle of the 11- inch incision.The wound was reclosed using topical adhesive.The surgeon opined that the patient higher bmi and significant swelling after surgery may have contributed to the dehiscence.The patient is currently doing fine.Additional information was requested.

• Brand Name: STRATAFIX SPIRAL MONOCRYL+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7355289
• Report Number: 2210968-2018-71543
• Device Sequence Number: 1220821
• Product Code: GAM
• UDI-Device Identifier: 10705031236639
• UDI-Public: 10705031236639
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SXMP1B110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/20/2018
• 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