MAUDE Adverse Event Report: SYNTHES GMBH RFNA / 12MM / 420MM STANDARD BEND / STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.242S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
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.D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown plates: femur/unknown lot.Part and lot numbers are unknown; udi number is unknown.D6b: explantation date was an unknown day in (b)(6) 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a lawyer.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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
It was reported that on or about (b)(6) 2022, the patient sustained injuries as a result of tripping and falling.On (b)(6) 2022, the surgeon performed a right femur distal fracture repair.In (b)(6) 2023, the patient underwent a second surgery due to infection.Hardware was replaced.No further information is available.This report involves one unk - plates: femur.This is report 1 of 2 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: device was used for treatment, not diagnosis.
Event or Problem Description
On (b)(6)2022 after a mechanical fall from standing, imaging showed right distal femur fracture and left proximal humerus fracture.On (b)(6)2022 the patient underwent imn of right femur.Orif of left humerus fracture on (b)(6)2022.He was discharged for acute rehab on june 01, 2022.On (b)(6)2023 the patient was admitted for right femur nonunion revision, with worsening right thigh pain and impaired mobility.The patient was for antibiotic management of right femoral osteomyelitis.
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 history: manufacturing location: monument.Manufacturing date: 08-apr-2021.Expiration date: unknown.Part number: 04.233.2342s, rfn/12mm/420mm 5 degree bend/pe inlay/sterile.Lot number: 79p4421 (sterile).Lot quantity: (b)(4).Two pieces scrapped at op 20 for tooling chipped.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / met all inspection acceptance criteria.Inspection sheet, rfn assembly inspection, met all inspection acceptance criteria.Packaging boms were reviewed and determined to be conforming with no deviations to normal packaging identified.Four pieces were reworked to confirm depth of inlay and sent back to fruh for repackaging and re-sterilization.Scn 62592 was reviewed and met specified dose ranges.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 ¿infection related to surgery¿ 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.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.
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 / 12MM / 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 ave; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17343776
• Report Number: 8030965-2023-08881
• Device Sequence Number: 6903170
• Product Code: HSB
• UDI-Device Identifier: 10886982290908
• UDI-Public: (01)10886982290908
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/18/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2026
• Device Catalogue Number: 04.233.242S
• Device Lot Number: 79P4421
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 08/15/2023; 08/15/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/08/2023; 08/15/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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: UNK - SCREWS: DISTAL FEMUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male