MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Material Rupture (1546)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

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: journal of hand surgery (british and european volume, 1999) 24b: 2: 148¿151.

Event Description

It was reported in journal article title : the mantero flexor tendon repair in zone 1 author: d.Guinard, f.Montanier, d.Thomas, d.Corcella and f.Moutet citation: journal of hand surgery (british and european volume, 1999) 24b: 2: 148¿151.This case study reported the authors¿ experience in 24 zone 1 flexor digitorum profundus (fdp) lesion repairs using the nylon loop suture technique.Between 1994 and 1996, 24 simple zone 1 fdp tendon lacerations were treated.There were 15 men and five women aged 15¿63 years were included in the study.Thirteen patients had clean cut transections and 13 injuries occurred at work.The injury affected the index finger in nine cases, the long in seven cases and the ring and little digits were each affected in four cases.Four patients had fdp divisions in two adjacent fingers and the tendon section was partial in two cases.Fourteen cases were associated with neurovascular bundle lesion and 13 single nerve lacerations and 7 single artery injuries.One presented with division of both bundles.The injuries were treated within 24 hours and all patients followed the grenoble rehabilitation regimen.A straight needle with 2/0 monofilament nylon suture (ethicrin®, ethicon) was passed from the tip of the pulp to the proximal stump.The suture was knotted over a silicone disc and clothes button and the repair site was reinforced with a running 6/0 polydioxanone suture (pds®, ethicon).After completion of the sheath closure, tendon gliding could be verified by a tenodesis effect.Four cases had complications.There were two localized and minor infections without any functional consequences, one moderate pulp dystrophy with a slight functional impairment, and one severe infection that led to a rupture.In conclusion, the authors concluded that usual tendon-to-bone repair techniques were inadequate to withstand the forces required for controlled active motion which contradicted the results obtained with the mantero technique.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• 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: 7397892
• MDR Text Key: 104409858
• Report Number: 2210968-2018-71906
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2018
• 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): Required Intervention