MAUDE Adverse Event Report: SYNTHES GMBH ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	04.168.495S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a ground-level fall and suffered a broken hip after a busy day at work teaching yoga.Despite her pain, patient initially attributed it to fatigue.But, as the discomfort worsened, she knew something was wrong.By 10am, she found herself in the emergency room, where she was diagnosed with a broken femur.The surgeon performed an open reduction with internal fixation on her hip and the patient underwent rehabilitation, diligently attending physical therapy sessions at the hospital and later at home.A month post-surgery, x-ray revealed complications from the initial surgery.The screw had snapped.Hardware removed from left hip consisting of three metallic medial devices and metallic screw.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: e3: initial reporter is a lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Epuy 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.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: 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.Device history review: a manufacturing record evaluation was performed for the finished device.Product code: 04.168.495s-us.Lot number: 69p6019.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 16 sep 2020.Manufacturing site: jabil grenchen.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 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.Added: g1 (manufacturing site name).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL
• 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 19380 ; 3035526892
• MDR Report Key: 21363215
• Report Number: 8030965-2025-01537
• Device Sequence Number: 12904831
• Product Code: KTT
• UDI-Device Identifier: 10886982274618
• UDI-Public: (01)10886982274618(17)300831(10)69P6019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.168.495S
• Device Lot Number: 69P6019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 02/27/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 02/19/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 TI LCKNG SCR SLF-TPNG T25 SD 40-SILE.; BOLT FOR FEMORAL NECK SYS 95 LENGTH-SILE.; FEMORAL NECK SYSTEM PL 1 HOLE - STERILE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female