MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 10MM/ 360MM/ STANDARD BEND/ STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.233.036S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023 that the patient experienced pain, nonunion, and wound infection.The wound infection required surgical intervention.The adverse event has been reported for subject (b)(6) for the dst202103 study: the adverse event term: acute left ankle pain & acute knee pain.Site awareness date: (b)(6) 2023.Start date: (b)(6) 2023.Type of event: local/fracture site.Device: rfna.This report is for one (1) rfna/ 10mm/ 360mm/ standard bend/ ster this is report 1 of 9 for complaint (b)(4).
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.H10 additional narrative: b5: subject (b)(6) for the dst202103 study.D2b.Additional pro-codes: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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.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.Manufacturing location: monument.Manufacturing date: 24-jan-2022.Expiration date: unknown.Part number: 04.233.036s, rfn/10mm/360mm 5 degree bend/pe inlay/sterile.Lot number: 551p608.(sterile) lot quantity: (b)(4) component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿adverse event: acute ankle and knee pain¿ 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.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RFNA/ 10MM/ 360MM/ STANDARD BEND/ STER
• 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16791640
• Report Number: 8030965-2023-05114
• Device Sequence Number: 5679261
• Product Code: HSB
• UDI-Device Identifier: 10886982289148
• UDI-Public: (01)10886982289148
• 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: Study,Health Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.233.036S
• Device Catalogue Number: 04.233.036S
• Device Lot Number: 551P608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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: LCKNG ATTACH WASHER RFNA / 5 DEG/ LT/ S; UNK - BIOMATERIAL - CEMENT: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 109 KG