MAUDE Adverse Event Report: SYNTHES GMBH UNK - REAMERS

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360)

Event Date 05/03/2023

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.This report is for an unk - reamers/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: (b)(6) colombia.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

Device report from synthes reports an event in colombia as follows: this report is being filed after the review of the following journal article: zuluaga, m.Et al (2023), orthoplastic management of distal tibia bone infection using masquelet technique and precice nail: a case report, trauma case reports vol.45 ((b)(4)), pages 1-8 (colombia).This study describes the experience of using an orthoplastic approach based on three stages in a patient with infected non-union of the tibial pilon.Presented, is a case of a 46-year-old man with septic non-union secondary to distal tibia fracture with a bone defect of 7 cm and severe soft tissue injury.This patient suffered a type iiia open fracture of the distal tibia and fibula of his right leg, managed with orif at another institution.The proposed management was divided into three stages: (1) eradication of the infection; (2) early bone and soft tissue reconstruction; (3) definitive skeletal reconstruction.The first stage began 28 weeks post injury with fistulectomy, resection of unstable scar and fibrosis, removal of osteosynthesis material, and radical debridement (soft tissues/non-union bone segment).At 31 weeks post injury, the second stage using an orthoplastic approach, an early skeletal reconstruction, acute shortening with fibula osteotomy, osteosynthesis of both distal tibia and fibula segments with a variable angle locking plate, and the first stage of mimt (pmma used), and a chimeric alt free flap was performed.On the third stage (37 weeks post injury), limb shortening with placement of a precice nail, proximal metaphyseal and diaphyseal osteotomy of the fibula, and second stage of mimt (pmma removed) replaced with a reamer-irrigator aspirator (ria, depuy synthes).At forty-nine weeks post injury (3 months after the last surgery), last stage of reconstruction was performed with a locking compression plate (lcp).At 79 weeks post injury and 42 weeks after the precice nail insertion, the nail was changed to an antibiotic-coated nail (tns protect®, depuy synthes) to avoid possible colonization and reactivation of infection.The following complications were reported as follows: - the patient had a residual valgus deformity at 49 weeks post injury; - the patient underwent a varus osteotomy of the distal tibia because of ankle pain when walking and some restrictions of activities of daily living.This report is for an unknown synthes reamer-irrigator aspirator (ria), unknown synthes lcp, and unknown synthes tns protect.This is report 1 of 3 for complaint unk - reamers.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - REAMERS
• Type of Device: REAMER
• 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: 18757737
• MDR Text Key: 335995216
• Report Number: 8030965-2024-02753
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention