ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
Report
- Report Number
- 2210968-2024-08623
- Event Type
- Injury
- Date Received
- August 22, 2024
- Date of Event
- January 1, 2024
- Report Date
- August 16, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- GAT
- PMA / PMN Number
- K946173
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: HAND 1¿7, HTTPS://DOI.ORG/10.1177/15589447241257558.
TITLE: A MODIFICATION TO THE BRAND TRANSFER FOR CLAW HAND: THE FOUR-TAILED EXTENSOR CARPI RADIALIS BREVIS TO LATERAL BAND TRANSFER. THIS STUDY PRESENTS A MODIFIED BRAND TENDON TRANSFER, WHICH EXTENDS THE EXTENSOR CARPI RADIALIS BREVIS INTO 4 TAILS FOR INDIVIDUAL GRAFTING INTO THE LATERAL BAND, DECREASING ADHESION RISK AND GRAFT LENGTH NEED. OVER A 5-YEAR PERIOD, 9 PATIENTS WHO UNDERWENT DYNAMIC TENDON TRANSFER USING A FOUR-TAILED TENDON TRANSFER WITH A MODIFIED WEAVE THROUGH THE EXTENSOR CARPI RADIALIS BREVIS TENDON WERE INCLUDED IN THE STUDY. THERE WERE 8 MALES AND 1 FEMALE WITH A MEAN AGE WAS 45.0 YEARS WITH AN AVERAGE FOLLOW-UP DURATION OF 1.1 YEARS (MIN: 6 MONTHS, MAX: 3.4 YEARS). THE 3-0 ETHIBOND SUTURES (ETHICON) WERE USED DURING THE BRAND TENDON TRANSFER PROCEDURE TO SECURE THE TENDON WEAVES. REPORTED COMPLICATIONS INCLUDED SLIGHT JOINT CONTRACTURES IN FLEXION OF THE INTERPHALANGEAL JOINTS (N=4) AND SCARRING/ADHESION IN THE EXTENSOR MECHANISM (N=1), AND HYPERMOBILITY OF THE SMALL FINGER METACARPOPHALANGEAL JOINT (N=1). IN CONCLUSION, OUR MODIFIED WEAVE OF A 4-TAILED TENDON GRAFT THROUGH THE EXTENSOR CARPI RADIALIS BREVIS IS A SYNERGISTIC TRANSFER THAT MAINTAINS ACCEPTABLE HAND STRENGTH IN THE SETTING OF A CHRONIC LOW ULNAR NERVE PALSY WITH A LOWER RISK OF TENDON ADHESION AND LENGTH OF GRAFTING, OFFERING AN ADDITIONAL TOOL IN THE ARMAMENTARIUM OF THE HAND SURGEON APPROACHING THE ULNAR NERVE¿INJURED HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1397475 | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |