MAUDE Adverse Event Report: SYNTHES GMBH 5.0 TI LCKNG SCR SLF-TPNG T25 SD 40-SILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	412.214S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
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 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: d4: udi: as the catalog/model number was not provided, the (01) gtin is not available.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
It was reported that the patient 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.On (b)(6) 2023 the surgeon performed an open reduction with internal fixation on her hip and underwent rehabilitation, diligently attending physical therapy sessions at the hospital and later at home.A month post-surgery, on (b)(6) 2023, x-ray revealed complications from the initial surgery.The screw snapped.On (b)(6) 2023 the screws removed from the left hip.
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.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: part number: 412.214s.Lot number: 2841p63.Manufacturing site: mezzovico.Release to warehouse date: 24 nov 2022.Expiration date: 31 oct 2032.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: it was reported that on (b)(6) 2023 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.On (b)(6) 2023 the surgeon performed an open reduction with internal fixation on her hip and underwent rehabilitation, diligently attending physical therapy sessions at the hospital and later at home.A month post-surgery, on (b)(6) 2023, x-ray revealed complications from the initial surgery.The screw had snapped either due to error or product malfunctioning.On (b)(6) 2023 hardware removed from left hip consisting of three metallic medial devices and metallic screw.
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: 5.0 TI LCKNG SCR SLF-TPNG T25 SD 40-SILE
• 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 MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21312473
• Report Number: 8030965-2025-01306
• Device Sequence Number: 20875254
• Product Code: KTT
• UDI-Device Identifier: 10886982275417
• UDI-Public: (01)10886982275417(17)321031(10)2841P63
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 412.214S
• Device Lot Number: 2841P63
• 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: 02/05/2025
• Supplement Report FDA Received Date: 02/19/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2022
• 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: ANTIROTATION SCR FEM NECK 95 LNTH -S.; 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