MAUDE Adverse Event Report: SYNTHES GMBH RFNA / 9MM / 200MM 5 DEGREE BEND / STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.233.920S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on an unknown date, the patient underwent a primary surgery with lcp-df implants.After the initial surgery on (b)(6) 2023, removal of lcp-df implants was performed and a revision with nail and tka was performed.During removal of the locking screws, the two proximal screws were difficult to remove and required use of a carbide drill to extract.While drilling for the 2nd most proximal screw of the rfna nail, the drill bit interfered with the nail.The drilling was attempted again after drilling the furthest proximal screw, but the bit missed the hole in the nail.Therefore, two people held the patient¿s femur in place to prevent movement, and the surgeon drilled with sleeves and were ultimately able to insert the two screws required.After completing rfna nail insertion, the surgeon performed tka.The procedures were completed successfully with 30 minutes of surgical delay.No further information is available.This report is for a rfna / 9mm / 200mm 5 degree bend / sterile.This is report 2 of 4 for (b)(4).
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes 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.

• Brand Name: RFNA / 9MM / 200MM 5 DEGREE BEND / STERILE
• 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: 16854727
• Report Number: 8030965-2023-05566
• Device Sequence Number: 7566767
• Product Code: HSB
• UDI-Device Identifier: 10886982288523
• UDI-Public: (01)10886982288523
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.233.920S
• Device Catalogue Number: 04.233.920S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/02/2023
• 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: DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QUIC; LCP-DF 4.5/5 LE 7HO L196 TAN; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Sex: Unknown