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

Catalog Number	SXMP1B109
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 layer was each suture used? which suture broke? will photo be returned for analysis? event date.Procedure date.Tissue type where each device was used.Did patient return with any symptoms? explain.Which tissue dehisced? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how large was the dehiscence? device used where dehiscence occurred.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? was the suture found broken during post-op examination or during any re-operation? was there any precipitating stress factor for the sutures untying, breakage or pulling out of the tissue? what in the physician¿s opinion caused the dehiscence? what medical/surgical intervention was provided to manage dehiscence? please provide operation notes.Patient initials, gender, age, date of birth, weight.Patient¿s present condition.Lot numbers of device used.
Event or Problem Description
It was reported that a patient underwent a total hip replacement procedure on an unknown date and barbed suture was used.Approximately 4-6 weeks post operatively the patient had a big fall and the patient's wound dehisced.The patient returned for reclosure of the wound.It was possible that the barbed suture was broken in the middle.Additional information has been 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: 7470736
• Report Number: 2210968-2018-72421
• Device Sequence Number: 107378
• Product Code: GAM
• UDI-Device Identifier: 10705031236608
• UDI-Public: 10705031236608
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/10/2018

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: No Information
• Device Catalogue Number: SXMP1B109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/27/2018
• 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