MAUDE Adverse Event Report: SYNTHES GMBH NUT 14MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.045.781S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.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 was implanted with a retrograde femoral nail advanced (rfna) on (b)(6) 2025.An open reduction and retrograde intramedullary nailing of the left femur surgery occurred on (b)(6) 2025.Post-operatively x-rays showed significant back-out and the screw was prominent.The patient had limited fracture healing at that point, so the patient underwent a revision procedure on (b)(6) 2025, for screw exchange and placement of a locking nut that threads onto the screw.Later it was discovered that the locking nut and screw were disengaged, and the screw was partially backed out.On (b)(6) 2025, another surgery was performed for left femur removal of hardware, revision of im nailing.Post-operative follow-up indicate that the patient appears stable, and imaging showed no loosening or failures at the present time; the fracture alignment remains stable.This report captures the second removal event that occurred on (b)(6) 2025.The first removal event that occurred on (b)(6) 2025, is captured on related complaint (b)(4).The third removal event that occurred on (b)(6) 2025, is captured on related complaint (b)(4).
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.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): a manufacturing record evaluation was performed for the finished device product code: 04.045.781s-us.Lot number: 916p076.It was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 03 aug 2022.Manufacturing site: jabil grenchen.Expiry date: 30 jun 2032.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
Additional information was received and states that: a.Please specify if there were other clinical findings: (e.G.Non-union, infection, allergic reaction, broken devices, etc.) the fracture was not far enough out to be a nonunion, just a fracture in the process of healing.Intraop cultures were normal.There was one proximal interlocking screw that was broken and one distal interlock that was broken on march 7 xrays.There was the mentioned disengagement of the threaded washer.B.Were laboratory tests taken due to the clinical findings? yes, we did take intraop cultures that were negative.

• Brand Name: NUT 14MM STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK GRENCHEN; solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22084217
• Report Number: 8030965-2025-05192
• Device Sequence Number: 20566714
• Product Code: HSB
• UDI-Device Identifier: 10886982295934
• UDI-Public: (01)10886982295934(17)320630(10)916P076
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2025

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: 04.045.781S
• Device Lot Number: 916P076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2022
• 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: LOCKING SCREW FOR IM NAIL 5/ 38/ XL25.; LOCKING SCREW FOR IM NAIL 5/ 86/ XL25.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White