MAUDE Adverse Event Report: SYNTHES GMBH FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 04.168.000S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent osteosynthesis for femoral neck fracture with the fns implants.Because the plate in question was inserted at an angle of slightly more than 130°, the distal part of the plate was fixed with the plate floating about 2 to 3 mm from the bone.The surgery was completed successfully without any surgical delay.After the surgery, on (b)(6) 2021, the patient complained of pain and foreign body sensation in the part where the plate was floating.Therefore, it was decided to remove the plate.The date of the removal surgery is unknown.Since the fracture part had bone-union, the surgeon decided to remove all of the implants.No further information is available.This report is for one (1) femoral neck system plate 1 hole - sterile.This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.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: FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12210339
• MDR Text Key: 262876799
• Report Number: 8030965-2021-05952
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089687
• UDI-Public: (01)07612334089687
• Combination Product (y/n): N
• PMA/PMN Number: K172872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.000S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 09/03/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - SCREWS: FNS LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR