MAUDE Adverse Event Report: SYNTHES GMBH BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.168.280S

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthese reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent an unknown surgery with the fns for a femoral neck fracture.The surgery was completed successfully without any surgical delay.However, cut-out of the bolt was suspected immediately after the surgery, and the surgeon had been following up with the patient.Postoperative x-ray showed the implant sliding and 1 to 2 mm cut-out of the bolt.A revision surgery is undecided.No further information is available.This report involves one bolt for femoral neck system 80mm length-sterile.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: only the event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6).Reporter is a j&j employee.Part number: 04.168.280s lot number: 452p936 manufacturing site: grenchen release to warehouse date: (b)(6) 2021 expiry date: (b)(6) 2031 a manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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.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: BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15692280
• MDR Text Key: 302678823
• Report Number: 8030965-2022-09032
• Device Sequence Number: 1
• Product Code: KTT
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.280S
• Device Lot Number: 452P936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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 L40 TAN; PL 1-HO F/FEM NECK SYST TAN
• Patient Outcome(s): Required Intervention
• Patient Sex: Male