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 Problems Pain (1994); 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.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.Does the surgeon believe that ethicon products (ethibond suture and ethilon suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (ethibond suture and ethilon suture) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics.Citation: ann plast surg.2020; 84: 154¿162.Doi: 10.1097/sap.0000000000002063.Note: events reported via mw # 2210968-2020-02133.(b)(4).

Event Description

It was reported via journal article: "title: suture suspensionplasty using abductor pollicis longus and flexor carpi radialis for advanced thumb carpometacarpal joint arthritis".Authors: sang ki lee, md, sang beom ma, md, and won sik choy, md.Citation: ann plast surg.2020; 84: 154¿162.Doi: 10.1097/sap.0000000000002063.Current operative treatment for advanced thumb carpometacarpal (cmc) joint arthritis mainly constitutes complete trapeziectomy with or without additional stabilizing procedures.However, it is unclear whether the additional procedures influence overall clinical outcomes.The purpose of this retrospective study was to evaluate the effectiveness of our post-trapeziectomy suture suspensionplasty technique, performed using the abductor pollicis longus and flexor carpi radialis tendons, in patients with advanced thumb cmc arthritis.The authors evaluated 36 thumbs in 35 patients (age range: 49 to 73 years old; 12 male and 23 female patients) with advanced thumb cmc arthritis treated with combined operative excision of trapezium followed by a suture suspensionplasty using flexor carpi radialis and abductor pollicis longus tendons.During the procedure, after the trapeziectomy, a longitudinal distracting force was applied to the thumb distally exposing the fcr insertion onto the base of the index metacarpal.While maintaining the longitudinal traction, an ethibond 5-0 suture (ethicon) was passed through the insertion point of the ulnar slip of the apl tendon from the outside to the inside of the trapezial space.It was then passed through the insertion point of the fcr tendon.The suture was further passed through the apl insertion and the dorsal capsule, thus reentering the trapezial space.The suture was drawn through the fcr insertion point again, creating a suspension-sling construct within the empty space.The basal joint capsule and soft tissue was then closed over the ethibond knot (ethicon) with a 3-0 polysorb suture to prevent irritation from the non-absorbable knot.Finally, the skin closed with ethilon 5-0 (ethicon), and small penrose drain is inserted for preventing hematoma formation in the surgical site.Reported complications included residual pain (n-3) in which the pain resolved by 3 months post-operatively without any treatment, persistent and continuous pain around the metacarpophalangeal joint and developed a progressive hyperextension deformity (n-1) in which the patient underwent mcp joint arthrodesis at 15 months post-operative and the patient experienced pain relief, superficial wound infection (n-1) which required oral antibiotics.This study demonstrated that suture suspensioplasty can be used as an alternative stabilizing procedure after trapeziectomy in patients with advanced thumb cmc arthritis.Significant improvement were noted in the rom of the operated thump mcp joint with relief of symptoms.In conclusion, the procedure with non-absorbable suture material and using the fcr and apl tendons is an effective post-trapeziectomy stabilization procedure.This surgical procedure provides satisfactory clinical outcomes and could be used as an alternative stabilization method after a complete trapeziectomy.

• 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
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9841506
• MDR Text Key: 191541998
• Report Number: 2210968-2020-02134
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• 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