MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE; NAIL, FIXATION, BONE

Model Number 04.043.240S

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2022

Event Type  Injury  

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 device product codes: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).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

It was reported that an adverse event occurred for subject (b)(6) for the dst202103 study.The patient¿s initial injury occurred on (b)(6) 2022 with right side polytrauma.Tna was implanted for closed distal tibia fracture.Date of index procedure was (b)(6) 2022.Compartment syndrome was noted to have started on (b)(6) 2022, and required fasciotomies of two compartments with irrigation and debridement.The implants were not removed.The status of the adverse event is now recovering/resolving.This report involves one tibial nail-advanced / 10mm 360mm / sterile.This is report 1 of 7 for (b)(4).

• Brand Name: TIBIAL NAIL-ADVANCED / 10MM 360MM / 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 19380 ; 3035526892
• MDR Report Key: 15977321
• MDR Text Key: 305448600
• Report Number: 8030965-2022-11060
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982297792
• UDI-Public: 10886982297792
• 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: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.043.240S
• Device Catalogue Number: 04.043.240S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• 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: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 99 KG