MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 13 420 / STERILE; NAIL, FIXATION, BONE

Model Number	04.043.560S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The ae has been reported for subject (b)(6) for the (b)(6) study: subject id: (b)(6).Adverse event: infection.Site awareness date: 20 december 2022.Start date: (b)(6) 2022.Serious: yes.Relationship to study device: possible.Relationship to study procedure: causal relationship.This report is for an unk ¿ nail.This is report 1 of 5 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.This report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: initial reporter is a synthes employee.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
The patient underwent surgery to implant a left side tna on november 23, 2022 after sustaining an open distal tibial fracture.On (b)(6)2022, incisional drainage was noted and traumatic wound infection was diagnosed.The patient was treated with oral/topical medication (keflex 500mg tid, bactrim ds 800mg/160mg bid).Irrigation and debridement was performed at the surgical site on (b)(6)2022.The outcome was recovered/resolved.At their 3-month and the 6-month follow-up visits, bone union had not yet been achieved.A bone stimulator was used for treatment.The outcome was recovering/resolving.

• Brand Name: TIBIAL NAIL-ADVANCED / 13 420 / STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16159023
• Report Number: 8030965-2023-00505
• Device Sequence Number: 20723582
• Product Code: JDS
• UDI-Device Identifier: 10886982297983
• UDI-Public: (01)10886982297983
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,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 Model Number: 04.043.560S
• Device Catalogue Number: 04.043.560S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American