MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11MM 360MM / STERILE; NAIL, FIXATION, BONE

Catalog Number	04.043.340S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: d2: additional procode: hwc.D9: complainant part is not expected to be returned for manufacturer.Review/investigation.E3: reporter is a synthes employee.H3, h6: a manufacturing record evaluation was performed for the finished device.Product code: 04.043.340s-us lot: 3537p08 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 03-january-2023.Manufacturing site: jabil bettlach.Expiry date: 30-november-2032.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.H6 component code: g07002 ¿ device not returned.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
Study: depuy clinical adverse event received for infected nonunion.Device relatedness: no information provided.Procedure relatedness: no information provided.Date of event: no information provided.Device location: right.Treatment/impact: surgical intervention at the fracture site.Depuy synthes products used: tna.This report is for a tibial nail-advanced / 11mm 360mm / sterile.This is report 1 of 9 for (b)(4).

• Brand Name: TIBIAL NAIL-ADVANCED / 11MM 360MM / STERILE
• Common Device Name: 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 19380 ; 3035526892
• MDR Report Key: 20030508
• Report Number: 8030965-2024-10151
• Device Sequence Number: 8566258
• Product Code: JDS
• UDI-Device Identifier: 10886982298249
• UDI-Public: (01)10886982298249(11)230103(17)321130(10)3537P08
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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

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 Catalogue Number: 04.043.340S
• Device Lot Number: 3537P08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• 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: END CAP/ 5MM/ STERILE; UNK - NAIL HEAD ELEMENTS: HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 44 KG