MAUDE Adverse Event Report: SYNTHES GMBH RFNA / 11MM / 420MM STANDARD BEND / STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.142S
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
Event or Problem Description
It was reported that the procedure involved the removal of the va condylar plate and retrograde femoral nailing system (rfna) due to non-union of the femur.This report is for one (1) rfna / 11mm / 420mm standard bend / sterile.This is report 4 of 10 for 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photos.Visual analysis of the photo revealed that rfna/ 11mm/ 420mm/ standard bend/ ster presented no evidence of a device nonconformance relation of the product with the reported adverse event.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for rfna/ 11mm/ 420mm/ standard bend/ ster.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: device history record (dhr) review conducted: manufacturing location: monument manufacturing date: 18-jun-2021 expiration date: unknown part number: 04.233.142s-us, rfn/11mm/420mm 5 degree bend/pe inlay/sterile lot number: 76p3451 (sterile) lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Note: this lot was returned in error from the sterilization supplier.The order was not in any bounding for a nonconformance and was reworked to the op210, ship order.Inspection sheet, in-process / inspect dimensional / final, met all inspection acceptance criteria.Inspection sheet, rfn assembly inspection, met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Note: scn was recorded on the production order traveler.The scn was reviewed and met specified dose ranges however, there was no linkage to specific lot numbers within the document.There was no pll included in this dhr.Therefore, the pll for this lot could not be reviewed and the expiration date could not be notated.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal due to non-union of the femur¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterilization, and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Device was used for treatment, not diagnosis.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
This report is related to pc-001599917 which captures additional impacted devices.
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RFNA / 11MM / 420MM STANDARD BEND / 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: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 19354968
• Report Number: 8030965-2024-06473
• Device Sequence Number: 15358422
• Product Code: HSB
• UDI-Device Identifier: 10886982290694
• UDI-Public: (01)10886982290694
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 04.233.142S
• Device Lot Number: 76P3451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown