MAUDE Adverse Event Report: SYNTHES GMBH BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.168.285S

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369)

Event Type  Injury  

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.Additional narrative: 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 Description

Device report from synthes reports an event in japan as follows: it was reported that on august 11,2022, the patient underwent orif for femoral neck fracture with femoral neck system.On (b)(6) the agency received the call that the surgeon decided to remove the femoral neck system.On (b)(6) he commented that he used the femoral neck system even though the patient walks independently and has a strong retroversion.He expected bony fusion but decided to replace it with an artificial head since it was displaced to the point of near cutout.The replacement surgery is planned on (b)(6).No further information is available.This report is for one (1) bolt f/fem neck syst f/construct length this is report 3 of 4 for complaint (b)(4).

• Brand Name: BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH
• Type of Device: 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
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15632757
• MDR Text Key: 302007534
• Report Number: 8030965-2022-08436
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089830
• UDI-Public: (01)07612334089830
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.285S
• Device Lot Number: 5L54225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; LOCKSCR Ø5 SELF-TAP L36 TAN; PL 1-HO F/FEM NECK SYST TAN
• Patient Outcome(s): Required Intervention
• Patient Sex: Female