MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.What was the date of the initial procedure? what tissue layer was the stratafix spiral pds suture used on? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? the patient demographic info: age, gender, weight, bmi at the time of index procedure? what post op date did the patient experience the fall at home? can you describe the size (in cms) of the patient dehiscence? how was the dehiscence managed? what was the date of the reoperation? what was the appearance of the suture during the second procedure? was the suture intact and pull away from the tissue? if suture broke, did it break at the initiation point, middle or end? does the surgeon believe there was any alleged deficiency of the suture? did the operating surgeon observe any suture deficiency or anomaly before, during, the suture placement? can you identify the lot number of the sxpp1b414 that was used? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status?.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty procedure on an unknown date in (b)(6) 2019 and suture was used.The patient is an ambient user and when she woke to use the restroom her knee flexed, and she fell breaking open the subcuticular layer of stitches causing a dehiscence.The patient returned to have the wound re-stitched.The patient current status is fine.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Bmi: around 30.

• Brand Name: STRATAFIX SPIRAL PDS+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8454619
• Report Number: 2210968-2019-79711
• Device Sequence Number: 10848750
• Product Code: NEW
• UDI-Device Identifier: 10705031235878
• UDI-Public: 10705031235878
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: No Information
• Device Catalogue Number: SXPP1B414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 68