MAUDE Adverse Event Report: SYNTHES GMBH 1.5 TI T-PL 4 HOLES HEAD/ 8 HOLES SHAFT; PLATE, FIXATION, BONE

Catalog Number 446.234

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094)

Event Date 06/28/2022

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: department of hand and reconstructive microsurgery, (b)(6) hospital, (b)(6).H3, h4, h6: 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 singapore as follows: this report is being filed after the review of the following journal article: tang, c.Q.Y., chuah, k.L., and teoh, l.C., (2022), metallosis following titanium implant use in the hand: a case report and review of current literature, journal of hand and microsurgery., vol.X (xx), pages 1-4 (singapore).This study presents a case of a 28-year-old lady presented with ulnar-sided right-hand pain in a few months¿ duration associated with erythema, which worsened with activity and upper limb load.She had previously undergone surgical fixation of right open ulnar fracture and right closed third, fourth, and fifth metacarpal base fracture 10 years ago in our institution following a road traffic accident.The patient had otherwise no significant past medical history, and no recent trauma or obvious etiology to explain the pain felt in her right hand.She also had no history of allergies or hypersensitivities to metals.On examination, there was hyperpigmentation over the dorsum of her right hand surrounding a well-healed surgical scar.Sensation over the dorsum of her right hand was normal, with no reported hyperalgesia or sudomotor changes.The range of motion over the wrist and fingers was full, and physical examination was otherwise unremarkable.Plain radiographs performed showed intact titanium plates, with no screws loosening.Due to symptoms, uncertain of chronic infection and functional limitations, the patient was keen for the removal of the surgical implants.During the removal of the metal implants from the fourth and fifth metacarpals by the senior author who is classified as an expert according to the tang and giddings¿ classification,7 an incision over the healed scar was made with dissection down to the implants.Inflammatory changes to the tissues from the skin to the depth of the implants with some areas of necrosis were found.Marked tenosynovitis of the extensor tendons and fibrotic scarring, with visibly darkened particulate matter, was seen.Intra-operative manipulative motion of the fifth metacarpal revealed the point of contact and friction between the proximal bases of the titanium plates, corresponding to the area of corrosion on the pure titanium plates.The histopathological examination of tissues revealed fibrovascular tissue with focal moderate chronic inflammatory cell infiltrate and focal hemosiderin stains as well as scattered metallic material deposited in the stroma.Tissue samples were also sent for microbiology tests which returned negative for bacterial, fungal, and acid-fast bacilli growth.Following intraoperative direct visualization and histopathological confirmation, metallosis was established as a cause of patient¿s symptoms.No further laboratory testing was performed in view of the patient¿s satisfaction and complete resolution of symptoms post-operatively.This report is for titanium plate (synthes 1.5mmt-plate implant no.446.233 and no.446.234).This is report 2 of 2 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: 1.5 TI T-PL 4 HOLES HEAD/ 8 HOLES SHAFT
• Type of Device: PLATE, 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: 18658229
• MDR Text Key: 334734972
• Report Number: 8030965-2024-02069
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• 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: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 446.234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• 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: 1.5 TI T-PL 3 HOLES HEAD/ 8 HOLES SHAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female