MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 11MM/ 380MM/ STANDARD BEND/ STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.138S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
Study id: depuy - (b)(6) subject id: (b)(6) it was reported that the patient suffered from a non union proximal femur fracture.This report is for one (1) rfna/ 11mm/ 380mm/ standard bend/ ster this is report 1 of 6 for complaint (b)(4).
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: e3: reporter is a j&j employee.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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 the patient was treated for a right-side distal femoral shaft fracture with an rfna nail on (b)(6) 2023.On (b)(6) 2024, non-union was diagnosed, and surgical intervention was performed at the fracture site.Plates/screws and bone grafting was performed.
Event or Problem Description
Study id: depuy - (b)(6) subject id: (b)(6) update: it was reported that: the answer to "is this a worsening of an existing event" changed to "no".The relationship to study device is marked as not related.The adverse event is expected/anticipated has been marked "yes".
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.H11 additional narrative: b5: additional information and correction added to complaint.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.H4, h6: a device history record (dhr) review was conducted: device history lot manufacturing location: monument manufacturing date: 08-jul-2022 expiration date: unknown part number: 04.233.138s, rfn/11mm/380mm 5° bend/pe inlay/sterile lot number: 852p914 (sterile) lot quantity: (b)(4) production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final rev d met all inspection acceptance criteria.Inspection sheet, rfn assembly inspection, rev b met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Note: scn 69611 was recorded on the production order traveler.The scn supplied by (b)(4) was reviewed and met specified dose ranges however, there was no linkage to specific lot numbers within the document.There was no pll included in this dhr.Therefore, the pll for this lot could not be reviewed and the expiration date could not be notated.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 ¿non-union proximal femur¿ 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 26-jan-2024: dhr reviewed this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Component parts were not reviewed as the reported complaint condition of ¿¿non-union proximal femur" does not indicate breakage of the or any of its components.Therefore, review of the raw materials would not be pertinent to the reported 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.

• Brand Name: RFNA/ 11MM/ 380MM/ STANDARD BEND/ STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 18622234
• Report Number: 8030965-2024-01739
• Device Sequence Number: 14045631
• Product Code: HSB
• UDI-Device Identifier: 10886982290670
• UDI-Public: (01)10886982290670
• 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: 2023
• 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,Followup,Followup
• Report Date (Section B): 02/01/2024

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: 04.233.138S
• Device Lot Number: 852P914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 02/05/2024; 05/23/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/15/2024; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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: NAIL LOCKING; UNK - SCREWS: NAIL LOCKING; UNK - SCREWS: NAIL LOCKING; UNK - SCREWS: NAIL LOCKING; UNK - SCREWS: NAIL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 74 KG