MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: injury int.J.Care injured.2008; 39: 1198¿1203.Doi: 10.1016/j.Injury.2008.05.008.[(b)(4)].

Event Description

It was reported via journal article: title: bridging-minimally invasive locking plate osteosynthesis (bridging-milpo): technique description with prospective series of 20 tibial fractures.Authors: timothy h.D.Williams, willem schenk.Citation: injury int.J.Care injured.2008; 39: 1198¿1203.Doi: 10.1016/j.Injury.2008.05.008.Bridging-milpo provides an alternative to other internal and external devices in the management of tibial fractures.The authors described a reproducible technique of bridging-minimally invasive locking plate osteosynthesis (bridging-milpo) in both metaphyseal and diaphyseal fractures of the tibia using a stainless steel locking compression plate (lcp) and locking screw.A total of 20 consecutive patients (14 male and 6 female patients; age range: 12 to 85 years old) with a unilateral tibial fracture were treated using bridging-milpo over a 31/2-year period between november 2003 and june 2007.During the surgical procedure, wound closure following saline wash was performed with interrupted ethilon (ethicon) to skin.Reported complications included case 2, a (b)(6)-year-old female patient with mild ankle pain, case 10, an (b)(6)-year-old female patient with wound infection which required oral antibiotics, case 14, a (b)(6)-year-old male patient with wound infection which required oral antibiotics.The hypothesized principle of relative stability was achieved through a locking plate.These show the plate in situ, bridging the fracture with a resultant lateral callus formation from the proposed micro-motion induced by immediate full weight bearing.Bridging-milpo has provided a typical pattern of fracture union through callus formation.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8587186
• MDR Text Key: 144309978
• Report Number: 2210968-2019-81127
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR