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

Model Number 04.043.560S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 procode: hwc complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthese 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 Description

Event from clinical study (b)(6) for subject (b)(6).Adverse event term: non union site awareness date: (b)(6) 2023 start date: (b)(6) 2023 type of event: local/fracture site side: left device: tna severity: mild serious: no relationship to study device: not related relationship to study procedure: possible this report is for a tibial nail-advanced / 13mm 420mm / sterile.This is report 1 of 5 for (b)(4).

• Brand Name: TIBIAL NAIL-ADVANCED / 13MM 420MM / STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 16582745
• MDR Text Key: 311674946
• Report Number: 8030965-2023-03446
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982297983
• UDI-Public: (01)10886982297983
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: NAIL LOCKING; UNK - SCREWS: NAIL LOCKING; UNK - SCREWS: NAIL LOCKING; UNK - SCREWS: NAIL LOCKING
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 112 KG