MAUDE Adverse Event Report: SYNTHES GMBH RFN-ADVANCED POLYMER INLAY STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	08.233.001S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6: photo investigation: the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The x-ray investigation revealed nothing indicative of a device nonconformance, since the polymer inlay is into the nail and cound to be observed in the evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the rfn-advanced polymer inlay would have not contributed to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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 approximately 1 year ago, the patient underwent an orif surgery with rfna implants and a slp for a femoral condylar fracture at another hospital.After the surgery, a revision surgery was scheduled due to non-union.The implants were removed, replaced with a competitor's products, and re-fixation was done successfully on (b)(6) 2025.No further information is available.

• Brand Name: RFN-ADVANCED POLYMER INLAY STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23020129
• Report Number: 8030965-2025-09174
• Device Sequence Number: 15962050
• Product Code: HSB
• UDI-Device Identifier: 10886982347572
• UDI-Public: (01)10886982347572
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 08.233.001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown