MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 10MM/ 320MM/ STANDARD BEND/ STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.032S
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H10 additional narrative: b3: unknown event date d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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 from a clinical study on unknown date that the distal interlock screw of a retrograde femoral nail advanced (rfna) system backed out.It was also noted there was infection and surgical intervention was required.Patient outcome listed as recovered/resolved.This report is for one rfna/ 10mm/ 320mm/ standard bend/ ster for complaint (b)(4).
Event or Problem Description
The initial complaint was reviewed and found not reportable.Report is a duplicate.Event is captured under 8030965-2024-04304.
Additional Manufacturer Narrative
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.H12 corrected data: b1, b5, h1: the initial complaint was reviewed and found not reportable.Report is a duplicate.Event is captured under 8030965-2024-04304.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/ 10MM/ 320MM/ 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: 18949683
• Report Number: 8030965-2024-03897
• Device Sequence Number: 7050485
• Product Code: HSB
• UDI-Device Identifier: 10886982289124
• UDI-Public: (01)10886982289124
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 04.233.032S
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown