MAUDE Adverse Event Report: SYNTHES GMBH FEMORAL NECK SYSTEM PLATE 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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: event occurred at an unknown date in (b)(6) 2022.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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 or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent initial surgery with fna implants for fracture of femoral neck.After surgery, around on (b)(6) 2022, the patient visited the hospital and complained of pain.On (b)(6) 2022, it was confirmed via x-ray that the plate telescoped, and the bone head was invaginated causing non-union.On (b)(6) 2022, revision surgery was performed via bha.This report is for a femoral neck system plate 1 hole - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: FEMORAL NECK SYSTEM PLATE 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; solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15013430
• Report Number: 8030965-2022-04833
• Device Sequence Number: 20547104
• 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: 2021
• Device Explanted Year: 2022
• 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?: 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female