MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 12MM/ 380MM/ STANDARD BEND/ STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.238S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	05/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional pro-code: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.H3, h4, h6: device history lot: manufacturing location: monument.Manufacturing date: 15-may-2023.Expiration date: 30-apr-2028.Part number: 04.233.238s, rfn/12mm/380mm std bend/pe inlay/sterile.Lot number: 6026p58 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection certificate met all inspection acceptance criteria.Packaging label logs (pll) lmd rev d were reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 25671 supplied by (b)(4) was reviewed and determined to be conforming this lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿adverse event: wound dehiscence¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: 24-may-2024: dhr reviewed.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that this study id: depuy - dst202103.Subject id: 01438-042 experienced a clinical adverse event.Received for r thigh wound dehiscence of the local/fracture site the principle investigator has not provided relationship information.However the: date of event: 05-may-2024.Date of implant: (b)(6) 2024.Date of revision: n/a.Device location: right distal femur.The surgical intervention was performed on (b)(6) 2024.Patient discharged from hospital (b)(6) 2024.Treatment: surgical intervention of irrigation and debridement.Depuy synthes products used: rfna and 5 locking screws catalog number: 04.233.238s.Lot number: n/a.Component type: (retrograde femoral nail advanced: 12mm: length 380mm).Description: the event is rated as severe and serious due to in-patient hospitalization or prolongation of existing hospitalization (admitted (b)(6) -2024), and resulted in medical or surgical intervention at the fracture site to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.This report is for one (1) rfna/ 12mm/ 380mm/ standard bend/ ster.This is report 1 of 6 for complaint (b)(4).

• Brand Name: RFNA/ 12MM/ 380MM/ STANDARD BEND/ STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19493069
• Report Number: 8030965-2024-07229
• Device Sequence Number: 15589952
• Product Code: HSB
• UDI-Device Identifier: 10886982290885
• UDI-Public: (01)10886982290885
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.233.238S
• Device Lot Number: 6026P58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown