MAUDE Adverse Event Report: SYNTHES GMBH 12/130 DEG TI CANN TFNA 420/RIGHT-SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.262S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complain had a broken hip pin after patient's 90-day check up after surgery.Patient initially broke their hip on (b)(6) 2024 and went to hospital where patient underwent the first surgery with implants inserted.Sometime between (b)(6) 2025, and (b)(6) 2025, patient experience an intense pain in their hip.Patient went back to er and x-ray showed that one of the pins on the hip implant was broken.Revision surgery was done on (b)(6) 2025, to replace the pin.Soon after the surgery, the patient got a local infection and is taking antibiotics.
Additional Manufacturer Narrative
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.Additional narrative: d4: udi: as the catalog/model number was not provided, (01)gtin is not available.
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.H.11.Additional narrative: added: a, a2 (dob), a3a, d4 (catalog, exp.Date & lot), g1, g4.Corrected: d1.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H.11.Additional narrative: added: d4 (primary udi number), e1 (initial reporter first name, last name), h4.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.If additional information is made available, the investigation will be updated as applicable.Device history review (dhr): manufacturing location: monument.Manufacturing date: 31-aug-2023.Expiration date: 31-jul-2033.Part number: 04.037.262s, 12mm/130 deg ti cann tfna 420mm/right ¿ sterile.Lot number: 7578p86 (sterile).Lot quantity: (b)(4).Nonconformance noted: n/a.A manufacturing record evaluation was performed for the finished device with batch number 7578p86.No nonconformities or manufacturing irregularities have identified related to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d10.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11.Additional narrative: added: d10 concomitant.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12/130 DEG TI CANN TFNA 420/RIGHT-SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22956359
• Report Number: 8030965-2025-08964
• Device Sequence Number: 9894155
• Product Code: HSB
• UDI-Device Identifier: 10886982097422
• UDI-Public: (01)10886982097422(17)330731(10)7578P86
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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: 04.037.262S
• Device Lot Number: 7578P86
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 09/17/2025; 09/18/2025; 04/15/2026
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/16/2025; 09/17/2025; 09/22/2025; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: 3.5 VA LCKNG SCR SLF-TPNG/SD/22; 3.5 VA LCKNG SCR SLF-TPNG/SD/24; 3.5 VA LCKNG SCR SLF-TPNG/SD/28; 3.5 VA LCKNG SCR SLF-TPNG/SD/28; 3.5/4.5 VA PROX FEM HOOK PL/SM/211/RT/S; 4.5MM CORTEX SCREW SELF-TAPPING 44MM; 4.5MM CORTEX SCREW SELF-TAPPING 46MM; LOCKSCR F/NAILS Ø5 L 38 XL25; TFNA FEM NAIL Ø11 130° L170 TIMO15; TFNA HELICAL BLADE PERF L115 TAN; TRAUMACEM V+ BONE CEMENT INJECTABLE; UNK - NAIL HEAD ELEMENTS: HELICAL BLADE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male