UNK - ELASTIC NAILS: TITANIUM

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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 DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BRATTGJERD JE, AASHEIM C, ROSENBERG A, FOTLAND C, HALVORSEN V. LONG-TERM IMPLANT RETENTION AFTER IMPACTED ELASTIC STABLE INTRAMEDULLARY NAILING IN PEDIATRIC DIAPHYSEAL FOREARM FRACTURES: A RETROSPECTIVE COHORT STUDY. ACTA ORTHOP. 2026 APR 1;97:225-231. DOI: 10.2340/17453674.2026.45693. PMID: 41921102; PMCID: PMC13044701. OBJECTIVE/METHODS/STUDY DATA: IN ELASTIC STABLE INTRAMEDULLARY NAILING (ESIN) FOR FOREARM FRACTURES, NAIL PROTRUSION MAY CAUSE IRRITATION-RELATED IMPLANT REMOVAL. THE PRIMARY AIM WAS TO EVALUATE IMPLANT RETENTION AFTER NAIL IMPACTION, AND SECONDARILY TO ASSESS SECONDARY PROCEDURES, COMPLICATIONS, AND PROTRUSION AS A PREDICTOR OF REMOVAL. A RETROSPECTIVE COHORT WAS ANALYZED OF CHILDREN WITH DIAPHYSEAL FOREARM FRACTURES TREATED WITH IMPACTED ESIN BETWEEN 2017 AND 2024. 160 CHILDREN WITH DIAPHYSEAL FOREARM FRACTURES WERE INCLUDED. AT A MEAN OBSERVATION TIME OF 5 YEARS, 132/160 CHILDREN RETAINED THEIR IMPLANTS (83%, 95% CONFIDENCE INTERVAL [CI] 76¿88). SECONDARY PROCEDURES OCCURRED IN 30/160 PATIENTS (19%, CI 13¿26), MOST COMMONLY IRRITATION-RELATED IMPLANT REMOVAL (10%, CI 6¿16) AND REFRACTURE (6%, CI 3¿10). COMPLICATIONS OCCURRED IN 19/160 PATIENTS (12%, CI 7¿18), INCLUDING SUPERFICIAL RADIAL NERVE SYMPTOMS (7/160; 4.4%) AND IRRITATION WITHOUT IMPLANT REMOVAL (6/160; 3.8%). A PROTRUSION THRESHOLD OF 3.3 MM PREDICTED IRRITATION-RELATED IMPLANT REMOVAL (AUC 0.79, CI 0.71¿0.86; SENSITIVITY 100%, CI 83¿100; SPECIFICITY 55%, CI 49¿61). NO IRRITATION-RELATED REMOVALS OCCURRED BELOW THIS THRESHOLD. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TITANIUM ELASTIC NAILS (TEN; DEPUY SYNTHES, OBERDORF, SWITZERLAND) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL (QTY 49): (N=16) LOCAL IRRITATION; TEN REMOVAL WAS PERFORMED IN 14 PATIENT AT THE RADIAL SITE, 5 PATIENT AT THE ULNAR SITE. TEN SHORTENING WAS PERFORMED IN 1 PATIENT AT THE ULNAR SITE. (N=9) REFRACTURE; TREATMENT CONSISTED OF IMPLANT REMOVAL AND REVISION FIXATION, AS IN MOST REFRACTURES. (N=3) INFECTION; TEN REMOVAL WAS PERFORMED IN 2 PATIENTS AND TEN REMOVAL + DEBRIDEMENT PROCEDURES IN 1 PATIENT. (N=1) MALALIGNMENT; TEN REMOVAL (N=1) NERVE DEFICIT; NERVE EXPLORATION (N=11) POSTOPERATIVE NERVE SYMPTOMS PRIMARILY INVOLVING THE SUPERFICIAL RADIAL NERVE (N=7) AFTER IMPLANT INSERTION IN 6 PATIENT OR REMOVAL IN 1 PATIENT. OTHERS INVOLVES WERE 2 IN RADIAL, 1-ULNAR, 1-MEDIAN OCCURRED; CONSERVATIVE MANAGEMENT (N=6) LATE-ONSET DISCOMFORT WITHOUT SUBSEQUENT IMPLANT REMOVAL; CONSERVATIVE MANAGEMENT (N=2) REDUCED FOREARM ROTATIONS: CONSERVATIVE MANAGEMENT ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - ELASTIC NAILS: TITANIUM (QTY 261): (N=133) NAIL PROTRUSION < 3.3 MM; NAILS WERE RETAINED. (N=128) NAIL PROTRUSION > 3.3 MM/ IRRITATION; 20 NAILS WERE REMOVED.