SUTURE UNKNOWN

Description of Event or Problem

TITLE: MODIFIED MA-GRIFFITH PERCUTANEOUS REPAIR VERSUS OPEN REPAIR OF ACUTE ACHILLES TENDON RUPTURE. THIS STUDY AIMS TO COMPARE THE CLINICAL OUTCOMES OF MODIFIED MA-GRIFFITH PERCUTANEOUS REPAIR (PR) VERSUS CONVENTIONAL OPEN REPAIR (OR) OF ACUTE CLOSED ACHILLES TENDON RUPTURE. BETWEEN JULY 2015 TO FEBRUARY 2020, A TOTAL 72 PATIENTS UNDERWENT SURGICAL TREATMENT OF ACHILLES TENDON RUPTURE, WHERE 38 PATIENTS UNDERWENT PR, WHILE THE OTHER 34 PATIENTS RECEIVED OR. IN THE PR GROUP, TWO SIZE 2 ETHICON SUTURES WERE PASSED TRANSVERSELY THROUGH THE ACHILLES TENDON THROUGH THE INCISION PROXIMAL AND DISTAL TO THE BROKEN END OF THE 18-GAUGE LUMBAR PUNCTURE NEEDLE, RESPECTIVELY, AND THEN PASSED OBLIQUELY THROUGH THE ACHILLES TENDON, RESPECTIVELY, AND THEN PASSED OUT FROM THE INCISION. IN THE OR GROUP, SIZE 2 ETHICON WAS USED TO PERFORM STUMP ANASTOMOSIS BY KESSLER METHOD, AND 2-0 VICRYL SUTURE WAS USED FOR CONTINUOUS SUTURE TO STRENGTHEN, REPAIR THE PARATENDINOUS TISSUE, AND SUTURE LAYER BY LAYER. REPORTED COMPLICATIONS ARE ETHICON SUTURES (BOTH GROUPS) N=3 ACHILLES TENDON RE-RUPTURE TREATMENT: REOPERATION N=9 GASTROCNEMIUS NERVE INJURY TREATMENT: ORAL MECOBALAMIN N=4 POSTOPERATIVE INCISION INFECTION TREATMENT: REGULAR DRESSING CHANGE, ANTIBIOTICS AFTER ANTI-INFECTION. VICRYL SUTURES (OPEN GROUP ONLY) N=3 ACHILLES TENDON RE-RUPTURE TREATMENT: REOPERATION N=1 GASTROCNEMIUS NERVE INJURY TREATMENT: ORAL MECOBALAMIN. IN CONCLUSION, THIS STUDY FOUND THAT COMPARED WITH THE DEVELOPMENT OF SURGICAL TREATMENT OF ACHILLES TENDON RUPTURE, THE EFFECT OF REPAIR SURGERY WAS SIMILAR, THE EARLY POSTOPERATIVE FUNCTIONAL RECOVERY WAS BETTER AFTER MINIMALLY INVASIVE SURGERY, BUT THE GASTROCNEMIUS NERVE INJURY WAS MORE LIKELY TO OCCUR IN THE REPAIR SURGERY, WHILE THE INCIDENCE OF INFECTION AFTER OPEN SURGERY WAS SIGNIFICANTLY HIGHER THAN THAT IN THE REPAIR SURGERY. THIS STUDY IS A SMALL SAMPLE RETROSPECTIVE STUDY, WHICH NEEDS TO BE FURTHER EXPLORED IN A LARGE SAMPLE PROSPECTIVE RANDOMIZED CONTROLLED STUDY.

Additional Manufacturer Narrative

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: HTTPS://DOI.ORG/10.3977/J.ISSN.1005-8478.2023.22.06.