MAUDE Adverse Event Report: SYNTHES GMBH FEMORAL NECK SYSTEM PL 1 HOLE - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.168.000S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes reports an event in japan as follows: it was reported that on an unknown date, the patient underwent an unknown surgery with the fns plate.Procedure was completed successfully without any surgical delay.After the surgery, femoral head osteonecrosis was confirmed.On february 17, 2023, the fns plate will be removed, and a tha will be performed.No further information is available.This report is for one (1) femoral neck system pl 1 hole - sterile.This is report 1 of 4 for complaint (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.H4 device history review product code: 04.168.000s, lot number: 883p330, manufacturing site: jabil grenchen, release to warehouse date:22/06/2022, expiry date:01/06/2032.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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: FEMORAL NECK SYSTEM PL 1 HOLE - STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16492405
• Report Number: 8030965-2023-02748
• Device Sequence Number: 17755314
• Product Code: KTT
• UDI-Device Identifier: 10886982274557
• UDI-Public: (01)10886982274557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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,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 Model Number: 04.168.000S
• Device Catalogue Number: 04.168.000S
• Device Lot Number: 883P330
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH; LOCKSCR Ø5 SELF-TAP L40 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown