MAUDE Adverse Event Report: AESCULAP AG & CO. KG MONOMAX VIOLET 1 (4) 150CM HR48 LOOP (M); SUTURE

Model Number B0041119

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Abdomen burst after 1 week, was sutured with monomax.During the re-operation; no remnants of the suture were found.

Manufacturer Narrative

Manufacturing site investigation: samples received: no samples available.There are no previous complaints of this code batch.(b)(6) units of this batch code were manufactured and distributed.There are no units in oem stock.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill oem requirements.Monomax is degraded by hydrolysis and via enzymatic pathways.The degradation process leads to a successive decrease of the material's tensile strength and finally to a complete mass absorption of the fiber.The mass absorption of monomax is essentially completed in between 13 months and more than 36 months, depending on the size of the suture material and the perfusion of the tissue in which the suture is implanted.In the warning notes/precautionary measures from the instructions for use of the product is it also explained that: monomax should be used applying the standard surgical suturing and knotting techniques, taking into account the surgeon's experience with the respective surgical procedure.Care should be taken that the knots are positioned properly and adequate knot security is given.A minimum of 4 correctly placed square and flat knots should be done.When working with monomax suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.Corrective/preventive actions: not applicable.

• Brand Name: MONOMAX VIOLET 1 (4) 150CM HR48 LOOP (M)
• Type of Device: SUTURE
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 7853 2
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona), es 0819 1
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4795744
• MDR Text Key: 5818274
• Report Number: 2916714-2015-00432
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K100876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0041119
• Device Catalogue Number: B0041119
• Device Lot Number: 114415
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other