MAUDE Adverse Event Report: SYNTHES GMBH ANTIROTATION SCR FEM NECK 75 LNTH -S; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	04.168.475S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional 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 ben able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employes that the report constitutes an admission that the device, depuy synthes, or its employes caused or contributed to the potential event described in this report.E3: reporter is a j&j employe.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has ben determined that no corrective and/or preventative action is proposed.This complaint wil be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation wil be updated as applicable.Device history lot a manufacturing record evaluation was performed for the finished device part: 04.168.475s-15, lot: 7219p01.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 22-aug-2023, manufacturing site:jabil grenchen, expiry date:01-aug-2033.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a folow-up medwatch wil be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent an orif with fns for femoral neck fracture.The surgery was completed successfully without any surgical delay.On (b)(6) 2024, a removal surgery was performed.The preoperative x-ray showed bone healing failure.No further information is available.This report involves one (1) antirotation scr fem neck 75 lnth -s.This is report 1 of 4 for (b)(4).

• Brand Name: ANTIROTATION SCR FEM NECK 75 LNTH -S
• 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): JABIL GRENCHEN; solothurnerstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20089860
• Report Number: 8030965-2024-10449
• Device Sequence Number: 7580920
• Product Code: KTT
• UDI-Device Identifier: 10886982274571
• UDI-Public: 10886982274571
• 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: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 08/28/2024

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 Catalogue Number: 04.168.475S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOLT FOR FEMORAL NECK SYS 75 LENGTH -S; LOCKSCR Ø5 SELF-TAP L40 TAN; PL 1-HO F/FEM NECK SYST TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown