MAUDE Adverse Event Report: SYNTHES GMBH ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM LENGTH - STERIL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 04.168.480S

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

Patient Problem Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date: (b)(6) 2021.Part # 04.168.480s, lot # 99p9856, manufacturing site: (b)(4)), release to warehouse date: 14.April.2021, expiry date: 01.April.2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for femoral neck fracture with the fns implants in question.The surgery was completed successfully without any surgical delay.After the surgery, the bone union failure was confirmed on an unknown date.A revision surgery performed on (b)(6) 2022.The fns implants were removed and replaced with tha.The patient was reported as stable.This report involves one (1) antirotation screw for femoral neck sys 80mm length: steril.This is report 3 of 4 for (b)(4).

• Brand Name: ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM LENGTH - STERIL
• 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 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14702763
• MDR Text Key: 294935711
• Report Number: 8030965-2022-04019
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982274588
• UDI-Public: (01)10886982274588
• 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: Physician
• 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
• Device Operator: Health Professional
• Device Model Number: 04.168.480S
• Device Catalogue Number: 04.168.480S
• Device Lot Number: 99P9856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH; LOCKSCR Ø5 SELF-TAP L40 TAN; PL 1-HO F/FEM NECK SYST TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female